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Sources: EU EUDAMED, US FDA
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Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. VASCULAR PACK, Model Number: DYNJ22350K, DYNJ22350L, DYNJ22676J, DYNJ23445F, DYNJ31902L, DYNJ31902M, DYNJ39432I, DYNJ39432J, DYNJ39432K, DYNJ41625B, DYNJ46246A, DYNJ53438A, DYNJ53610C, DYNJ53995G, DYNJ56791A, DYNJ56791B, DYNJ57490A, DYNJ58608, DYNJ58681A, DYNJ58681B, DYNJ58710, DYNJ61325A, DYNJ61325B, DYNJ61528, DYNJ62399A, DYNJ65160, DYNJ66356, DYNJ66356A, DYNJ66356B, DYNJ66356C, DYNJ66356D, DYNJ66577, DYNJ68492A, DYNJ68492B, DYNJ68492C, DYNJ68492D, DYNJ68863, DYNJ68863A, DYNJ68880, DYNJ80599, DYNJ81626, DYNJ82016, DYNJ82104, DYNJ82144, DYNJ82769, DYNJ82769A, DYNJ83146; b. VASCULAR PACK CHRG, Model Number: DYNJ59778A, DYNJ59778B; c. VASCULAR PACK GWV, Model Number: DYNJ59245; DYNJ59245A; d. VASCULAR PACK MH-LF, Model Number: DYNJ39866B, DYNJ39866C; e. VASCULAR PACK SHD, Model Number: DYNJ68404; f. VASCULAR PACK-LF, Model Number: DYNJ0250564O, DYNJ0250564P, DYNJ0373040N, DYNJ0493141G, DYNJ0493141I, DYNJ0493141J, DYNJ0871182AC, DYNJ0901358I, DYNJ0901358J, DYNJ0901358K, DYNJ53475F, DYNJ53684A, PHS400047N, PHS400047O; g. VASCULAR STENT INOVA, Model Number: DYNJ906440A; h. VASCULAR TRAY, Model Number: DYNJ56858; i. VASCULAR/OR ANGIO, Model Number: DYNJ905079F; j. VASCULAR-LF, Model Number: DYNJ900714B, DYNJ900714C; k. VEIN ABLATION EXCISION ASC, Model Number: DYNJ52586B; l. VEIN ABLATION & EXCISION ASC, Model Number: DYNJ52586, DYNJ52586A, DYNJ52586B; m. VEIN ABLATION KIT, Model Number: DYNJ69272A; n. VEIN ABLATION PACK, Model Number: DYNJ62889; o. VEIN ABLATION TRAY W/CHLOR, Model Number: DYNJ64396; p. VEIN AND LASER PACK, Model Number: DYNJ49874; q. VEIN CENTER PACK, Model Number: DYNJ52123; r. VEIN CLINIC, Model Number: DYNJ68667; s. VEIN CLOSURE PACK, Model Number: DYNJ35586G, DYNJ39408F, DYNJ65189B; t. VEIN CLOSURE TRAY, Model Number: DYNJ44737B; u. VEIN KIT, Model Number: DYNJ57047; v. VEIN LIGATION, Model Number: DYNJ64190; w. VEIN OHH, Model Number: DYNJ65560A; x. VEIN PACK, Model Number: DYNJ21949J, DYNJ39005B, DYNJ39889, DYNJ48493, DYNJ48907F, DYNJ50785, DYNJ52098, DYNJ52993A, DYNJ53160, DYNJ53160A, DYNJ54153B, DYNJ55268, DYNJ55462A, DYNJ55514A, DYNJ55849A, DYNJ56624, DYNJ56724A, DYNJ56724B, DYNJ57512, DYNJ57835, DYNJ57917, DYNJ58063, DYNJ58609, DYNJ59151F, DYNJ59662B, DYNJ59662D, DYNJ59677A, DYNJ59681A, DYNJ61540C, DYNJ63823, DYNJ64282, DYNJ64471A, DYNJ65579, DYNJ66154, DYNJ66743A, DYNJ68749, DYNJ69091, DYNJ80199A, DYNJ80199B, DYNJ80868, DYNJ83147; y. VEIN PACK II, Model Number: DYNJ66427; z. VEIN PACK-LF, Model Number: DYNJ66271A, DYNJ66271C; aa. VEIN PROCEDURE, Model Number: DYNJ65342A; bb. VEIN PROCEDURE PACK, Model Number: DYNJ38264D, DYNJ62038A, DYNJ64909; cc. VEIN SPECIALISTS PACK, Model Number: DYNJ53616A; dd. VEIN TRAY, Model Number: DYNJ57003, DYNJ62829A; ee. VENOUS ABLATION, Model Number: DYNJ50227C; ff. VENOUS ACCESS ACCESSORY PACK, Model Number: DYNJ61010A; gg. VENOUS ACCESS PACK, Model Number: DYNJ44421D; hh. VIRC STROKE PACK, Model Number: DYNJ83461; ii. VNUS, Model Number: CDS984292I; jj. VNUS CLOSURE, Model Number: DYNJ66076; kk. VNUS VASCULAR PACK, Model Number: DYNJ66445; ll. WA VASCULAR PACK-LF, Model Number: DYNJ33612G
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 9, 2023
MEDLINE convenience kits labeled as: 1) MAMMOPLASTY-LF, REF CDS983478L; 2) MAMMOPLASTY-LF, REF CDS983478M; 3) PLASTICS FREE FLAP, REF CDS983493M; 4) PLASTIC TORSO-LF, REF CDS983496L; 5) PLASTIC TORSO-LF, REF CDS983496M; 6) PLASTIC HEAD AND NECK-LF, REF CDS983498N; 7) ACH PLASTICS BREAST-LF, REF CDS983639J; 8) ACH PLASTICS BREAST-LF, REF CDS983639K; 9) BREAST ABD, REF CDS984267J; 10) DAY SURG PLASTIC CDS, REF CDS984993N; 11) DAY SURG PLASTIC CDS, REF CDS984993O; 12) DAY SURG PLASTIC CDS, REF CDS984993P; 13) PLASTIC PACK, REF DYNJ00264L; 14) LKLND BRST CHST PK RFID-LF, REF DYNJ0101536L; 15) OCULOPLASTY PACK-LF, REF DYNJ0252232U; 16) PLASTICS PACK, REF DYNJ02615G; 17) BREAST PBM-LF, REF DYNJ0318423M; 18) FLAP RECONSTRUCTION PACK-LF, REF DYNJ0378388P; 19) BREAST PACK-LF, REF DYNJ0378394R; 20) BREAST PACK-LF, REF DYNJ0378394S; 21) BREAST PACK-LF, REF DYNJ0378394T; 22) BREAST ABDOMINOPLASTY MZ PK-LF, REF DYNJ0428947K; 23) BREAST ABDOMINOPLASTY MZ PK-LF, REF DYNJ0428947L; 24) ASC MAJOR PLASTIC PACK-LF, REF DYNJ0854517M; 25) ASC ENT PLASTIC PACK-LF, REF DYNJ0854650J; 26) BREAST PACK-LF, REF DYNJ0956628M; 27) BREAST PACK-LF, REF DYNJ0956628N; 28) BREAST PACK-LF, REF DYNJ0956628O; 29) AUGMENTATION #87-RF, REF DYNJ27319U; 30) AUGMENTATION #87-RF, REF DYNJ27319V; 31) PLASTICS PACK-LF, REF DYNJ36107J; 32) PLASTIC MINOR PACK, REF DYNJ37620F; 33) CHEST/BREAST PACK, REF DYNJ39118C; 34) PLASTIC BREAST PACK, REF DYNJ40620C; 35) PLASTIC BREAST PACK, REF DYNJ40620D; 36) BREAST RECONSTRUCTION-HOULE, REF DYNJ44852M; 37) BREAST MINOR PK RFID, REF DYNJ52409J; 38) BREAST MAJOR PACK, REF DYNJ52435J; 39) BREAST MAJOR PK RFID, REF DYNJ52435K; 40) BREAST PACK, REF DYNJ57527C; 41) TRANSGENDER MASTECTOMY 2, REF DYNJ58257G; 42) BREAST PACK SSC, REF DYNJ59733A; 43) BREAST PACK, REF DYNJ60511B; 44) BREAST PACK, REF DYNJ60511F; 45) PLASTIC PACK, REF DYNJ61755B; 46) TYMPANOPLASTY, REF DYNJ63332D; 47) BREAST PACK, REF DYNJ63369D; 48) BREAST SURGERY FOAKS, REF DYNJ63577C; 49) MAJOR PLASTIC FOAKS, REF DYNJ63579C; 50) MAJOR PLASTIC PACK FAIRFAX, REF DYNJ63612C; 51) MAJOR BREAST WOMENS PACK, REF DYNJ63647C; 52) PLASTIC BASIN PACK, REF DYNJ63883B; 53) PLASTICS WOODBURN, REF DYNJ64001B; 54) BREAST PK, REF DYNJ64144B; 55) BREAST PK, REF DYNJ64144C; 56) PACK,PLASTIC, REF DYNJ65477B; 57) PACK,PLASTIC BASIC ASC, REF DYNJ65485A; 58) OSC BREAST PACK, REF DYNJ65808A; 59) CHEST/BREAST PACK, REF DYNJ66495A; 60) PLASTICS PACK, REF DYNJ66610B; 61) BREAST PACK, REF DYNJ66739B; 62) MAJOR PLASTICS PACK, REF DYNJ67968A; 63) BREAST PACK, REF DYNJ68464A; 64) FLAP PACK, REF DYNJ80179A; 65) PLASTICS PACK, REF DYNJ81797A; 66) PLASTICS PACK, REF DYNJ81811A; 67) MINOR PLASTICS PACK, REF DYNJ82196; 68) MINOR PLASTICS PACK, REF DYNJ82196A; 69) DELNOR MAJOR PLASTICS PACK, REF DYNJ82248; 70) DELNOR SIMPLE PLASTIC PACK, REF DYNJ82250; 71) DELNOR SIMPLE PLASTIC PACK, REF DYNJ82250A; 72) DELNOR AUGMENTATION PACK, REF DYNJ82265; 73) DELNOR AUGMENTATION PACK, REF DYNJ82265A; 74) AUGMENTATION PACK, REF DYNJ82279; 75) AUGMENTATION PACK, REF DYNJ82279A; 76) PLASTIC SURGERY PACK, REF DYNJ82352; 77) PLASTIC SURGERY PACK, REF DYNJ82352A; 78) FREE FLAP 2 PACK, REF DYNJ82659B; 79) FREE FLAP 1 PACK, REF DYNJ82660A; 80) FREE FLAP 1 PACK, REF DYNJ82660B; 81) FACE PACK, REF DYNJ83532; 82) BREAST RECONSTRUCTION PACK-LF, REF DYNJ83612A; 83) PLASTIC PACK, REF DYNJ83856; 84) BREAST PACK, REF DYNJ84332; 85) MAJOR PLASTIC PACK, REF DYNJ84827; 86) PLASTICS PACK, REF DYNJ84966; 87) PLASTIC PACK, REF DYNJ85702; 88) FACIAL PLASTICS FLAP PACK, REF DYNJ86031; 89) BREAST-CHEST, REF DYNJ900294K; 90) GENERAL PLASTIC-LF, REF DYNJ901738O; 91) TRAM RECONSTRUCTION-LF, REF DYNJ901753L; 92) PLASTIC UNIVERSAL, REF DYNJ901792J; 93) MID HUDSON BREAST, REF DYNJ903614C; 94) MID HUDSON BREAST, REF DYNJ903614D; 95) MID HUDSON BREAST, REF DYNJ903614F; 96) MID HUDSON PLASTICS, REF DYNJ903616F; 97) MID HUDSON PLASTICS, REF DYNJ903616G; 98) MID
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·December 11, 2024
Medline Convenience kits used for various procedures: 1) T A PACK, Model Number: DYNJ67791A; 2) NASAL PACK, Model Number: DYNJ66514; 3) ENT PACK, Model Number: DYNJ67775A; 4) T/A ENDO PACK, Model Number: DYNJ83158; 5) T & A PACK, Model Number: DYNJ0634878I; 6) PPM-ICD PACK-LF, Model Number: DYNJ15949D; 7) TONSIL PACK, Model Number: DYNJ44525C; 8) ENT TRAY, Model Number: DYNJ44391K; 9) ENT PACK, Model Number: DYNJ49300D; 10) NASAL PACK, Model Number: DYNJ61555B; 11) HEAD AND NECK, Model Number: DYNJ57287A; 12) SINUS ENDOSCOPY-LF, Model Number: DYNJ36720F; 13) ENT PACK, Model Number: DYNJ54035B; 14) ENT PACK, Model Number: DYNJ36516; 15) FESS PACK, Model Number: DYNJ59502B; 16) T AND A PACK, Model Number: DYNJ80790; 17) PK,ENT, Model Number: DYNJ57583; 18) ENT/LAP PACK, Model Number: DYNJ84876; 19) TONSIL PACK, Model Number: DYNJ50109B; 20) TONSIL, Model Number: DYNJ908452C; 21) CSS SINUS PACK, Model Number: DYNJ17005I; 22) ENT, Model Number: DYNJ910514; 23) ADULT ENT - OAKBEND, Model Number: DYNJ905762; 24) EENT SPLIT PACK-LF, Model Number: LLSCAENT01; 25) ENT PACK, Model Number: DYNJ31453D; 26) ENT PACK, Model Number: DYNJ59447A; 27) TONSIL PACK, Model Number: DYNJ26441R; 28) ORAL ENT PACK, Model Number: DYNJ58408A; 29) ENT PACK, Model Number: DYNJ51085; 30) DR LANO NASAL CHRISTUS, Model Number: DYNJ61196A; 31) ENT PACK, Model Number: DYNJ66178D; 32) BWNBORO EENT PACK-LF, Model Number: DYNJ37551A; 33) HEAD AND NECK PACK, Model Number: DYNJ68872F; 34) EENT PACK, Model Number: DYNJ50301C; 35) ENT PACK, Model Number: DYNJ40498B; 36) SHN-C-THYROIDECTOMY-LF, Model Number: DYNJ46869A; 37) MINOR CYSTO PACK, Model Number: DYNJ58727D; 38) TONSILS AND ADENOIDS, Model Number: DYNJ45171C; 39) T&A PACK, Model Number: DYNJ56543J; 40) ENT PACK, Model Number: DYNJ54035B; 41) TONSIL PACK, Model Number: DYNJ50109B; 42) ENT PACK, Model Number: DYNJ40139D; 43) NASAL/SEPTO PACK, Model Number: DYNJ32099A; 44) EENT SPLIT PACK-LF, Model Number: LLSCAENT01; 45) ENT PACK, Model Number: DYNJ53573A; 46) CHS ENT PACK II, Model Number: DYNJCH908; 47) SIMPLE NECK DISSECTION, Model Number: DYNJ47481F; 48) TONSIL PACK, Model Number: DYNJ81479A; 49) E.N.T. TRAY, Model Number: DYNJ22357K; 50) NASAL PACK, Model Number: DYNJ39317B; 51) HEAD AND NECK PACK, Model Number: DYNJ54321D; 52) T A PACK, Model Number: DYNJ67791A; 53) ENT PACK, Model Number: DYNJ42451B; 54) HEAD AND NECK PACK-FOX, Model Number: DYNJ53348C; 55) HEAD AND NECK PACK, Model Number: DYNJ58596B; 56) SINUS PACK, Model Number: DYNJ56262; 57) ENT PACK, Model Number: DYNJ51085; 58) TONSIL T AND A PACK SHD, Model Number: DYNJ68417C; 59) ENT PACK, Model Number: DYNJ48595; 60) T AND A PACK-LF, Model Number: DYNJ52611; 61) HEAD AND NECK PACK, Model Number: DYNJ81897B; 62) ENSEMBLE ORL THYROIDE-LF, Model Number: DYNJ43390A; 63) EENT PACK-LF, Model Number: DYNJ34728D; 64) ENT, Model Number: DYNJ910514; 65) TONSIL ADENOID CKHA-LF, Model Number: DYNJ41771C; 66) ENT PACK, Model Number: DYNJ68679B; 67) PACK,T & A ASC, Model Number: DYNJ906914; 68) EENT SPLIT PACK-LF, Model Number: LLSCAENT01; 69) ENT PACK, Model Number: DYNJ83603; 70) ENT PACK, Model Number: DYNJ32247; 71) PPM-ICD PACK-LF, Model Number: DYNJ15949D; 72) ENT PACK, Model Number: DYNJ31453D; 73) SINOSCOPY PACK-LF, Model Number: DYNJ25600L; 74) T & A PACK, Model Number: DYNJ38978C; 75) CSC-N T&A, Model Number: DYNJ50870D; 76) ENT I-LF, Model Number: DYNJS0702; 77) ENT KIT, Model Number: DYNJ902836F; 78) ENT PACK, Model Number: DYNJ66039B; 79) TONSIL CDS, Model Number: DYNJ907844D; 80) PACK,T & A ASC, Model Number: DYNJ906914
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 23, 2025
Medline Convenience kits labeled as: 1) UROLOGY MINOR CDS , Pack Number CDS980371J ; 2) UROLOGY MINOR CDS , Pack Number CDS980371K ; 3) CIRCUMCISION TRAY 1.1 , Pack Number CIT6260A ; 4) CIRCUMCISION TRAY 1.3 CM BELL , Pack Number CIT7740; 5) CIRCUMCISION TRAY , Pack Number DYNDL1813; 6) CIRCUMCISION PACK , Pack Number DYNJ16826M ; 7) CIRCUMCISION PACK , Pack Number DYNJ16826N ; 8) CIRCUMCISION PACK , Pack Number DYNJ16826O ; 9) CIRCUMCISION PACK , Pack Number DYNJ38941D ; 10) CIRCUMCISION PACK , Pack Number DYNJ38941F ; 11) CIRCUMCISION SJHC-LF, Pack Number DYNJ48471D ; 12) CIRCUMCISION SJHC-LF, Pack Number DYNJ48471F ; 13) CRMC UNIVERSAL PACK-LF, Pack Number DYNJ61119C ; 14) D-CIRCUMCISION PACK , Pack Number DYNJ64432; 15) CIRCUMCISION PACK , Pack Number DYNJ64876A ; 16) CIRCUMCISION PACK , Pack Number DYNJ64876B ; 17) PACK,CIRCUMCISION ASC , Pack Number DYNJ906909A
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024
Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit number AGKD50L; b) ROBOTIC PROSTATE PACK - 264852, kit number ANPR34S; c) LAP CHOLE - 213388, kit number BFLC02AD; d) GENERAL LAPAROSCOPY PACK, kit number GUGE09I; e) LAP CHOLE PACK, kit number HNLC80I; f) Lap Chole Ovarian Appy, kit number JSLC06I; g) LAP CHOLE, ST LUKES, kit number LMLP08Z; h) ROBOTIC PACK - 242561, kit number MHRB88AJ; i) KIT, GENERAL LAPAROSCOPY, kit number MMLP40F; j) KIT, MAJOR LAPAROTOMY, kit number MMML26F; k) LAP CHOLE - LAP HERNIA PACK - 282807, kit number OWLC07K; l) GENERAL LAPAROSCOPY SAH, kit number SAGL57H; m) ROBOTIC PACK SAH, kit number SARB30K; n) ROBOTIC PACK SAH, kit number SARB30L; o) ROBOTIC PACK SAH, kit number SARB30M; p) LAP CHOLE PACK, kit number SMLC53; q) ROBOTICS PACK, kit number SNRP85D; r) ROBOTIC PACK, kit number SSRO22C; s) ROBOTIC PACK, kit number SSRO22D; t) TPK DAVINCI PROSTATE SYSTEM, kit number TPDV16; u) ASC LAP CHOLE PACK (PS 42279), kit number UICH53Y; v) GENERAL LAPAROSCOPIC PACK, kit number WVGL60E
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·February 7, 2024
Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB DEVICE IMPLANT, kit number AGDI40J; c) LAB DEVICE IMPLANT, kit number AGDI40K; d) MINOR VASCULAR, kit number AGMV26O; e) OPEN HEART ACCESSORY, kit number AGOH98Q; f) OPEN HEART ACCESSORY, kit number AGOH98R; g) OPEN HEART ACCESSORY, kit number AGOH98S; h) PERIPHERAL VASCULAR, kit number AGPV28O; i) PERIPHERAL VASCULAR, kit number AGPV28P; j) MINOR VASCULAR, kit number AHMV26J; k) MINOR VASCULAR, kit number AHMV26K; l) HEART PACK - 205947, kit number ANCV78AX; m) HEART PACK - 205947 , kit number ANCV78AX1; n) HEART PACK - 205947 Post Open-Heart, kit number ANHK74N; o) OPEN HEART EAST PACK, kit number BHOH43; p) 74OFF PUMP CABG PACK, kit number BHOP48; q) PACEMAKER PACK, kit number BHPM60; r) FORBES EP LAB DEVICE IMPLANT PK, kit number FBDI42K; s) T AND A PACK AGH ASC, kit number FBDI42L; t) T AND A PACK AGH ASC, kit number FBDI42M; u) THORACOSCOPY PACK, kit number FBTO60G; v) OPEN HEART ACCESSORY PACK, kit number JROH00O; w) OPEN HEART ACCESSORY PACK, kit number JROH98O; x) ADULT OPEN HEART PACK, kit number LLOH52; y) ADULT OPEN HEART PACK, kit number LLOP25; z) PACEMAKER PACK, kit number LLPP14; aa) HEART PACK, kit number LMCB06AD; bb) CARDIAC HEART BUNDLE NS, kit number LMCH99O; cc) OPEN HEAART PACK, kit number LMOH50AD; dd) OPEN HEAART PACK, kit number LMOH50AD-01; ee) OPEN HEAART PACK, kit number LMOH50AD-02; ff) OPEN HEAART PACK, kit number LMOH50AE; gg) CV PACK, kit number MMCV98V; hh) CV PACK, kit number MMCV98V-03; ii) CV PACK, kit number MMCV98V-04; jj) KIT OPEN HEART ADULT, kit number MMOH64J; kk) PACEMAKER PACK, kit number MMPM27E; ll) KIT, THORACOTOMY UNIVERSAL, kit number MMTR12F; mm) ANT CERV FUSION PACK, kit number NCAC96; nn) OPEN HEART- ACCESSOR, kit number NCOH11; oo) VASCULAR SAH, kit number SAVA91G; pp) VASCULAR SAH, kit number SAVA91H; qq) VASCULAR SAH, kit number SAVA91I; rr) VASCULAR SAH, kit number SAVA91J; ss) OPEN HEART BRINGBACK SJH, kit number SJOH17I; tt) OPEN HEART CV SJH, kit number SJOH28L; uu) PEDIATRIC HEART SJH, kit number SJPH34K; vv) VASC OPEN CVOR SJH, kit number SJVO56A; ww) VASC OPEN CVOR SJH, kit number SJVO56B; xx) MAJOR CV TRAY, kit number SVMJ20L; yy) MAJOR CV TRAY, kit number SVMJ20M; zz) MINOR CV TRAY¿, kit number SVMN60J; aaa) OPEN HEART COMPONENT PACK, kit number SVOH38Q; bbb) CV B PACK, kit number TNCB10AK; ccc) CARDIOVASCULAR SUPPLY (PS 907285), kit number UICD62AM
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·February 7, 2024
Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; b) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; c) MINI MINOR AGH ASC PACK, kit number AGMM60M; d) OUTPATIENT PORT ACCESS KIT 307907, kit number AHPO55J; e) General Pack, kit number BBGP31C; f) FRACTURE TABLE PACK, kit number FDFT75N; g) Arthroscopy Pack, kit number HCAR04K; h) BARIATRIC PACK, kit number HGBA92F; i) LAPAROTOMY PACK, kit number HNLP12J; j) MIDLINE CHANGE KIT, kit number HSMD20E; k) Minor General, kit number JSMI10I; l) ENDO VASCULAR PACK, kit number LVEV61; m) MAJOR PACK, kit number LVMJ21; n) HEAD AND NECK PACK, kit number MMHN37F; o) KIT, MINOR U BAR, kit number MMNU34E; p) KIT, MAJOR UNIVERSAL, kit number MMUN28E; q) VAG PLASTY PACK, kit number OSVP16; r) DR L MAJOR, kit number SALM40H; s) DR L MAJOR, kit number SALM40I; t) MINOR BASIN SAH, kit number SAMB25E; u) MAJOR SAH, kit number SAMJ36G; v) MINOR PACK, kit number SMMN65; w) General Pack, kit number THGN59D; x) MINOR PACK, kit number TPMN15; y) MAJOR UNIVERSAL PACK, kit number TPUN48
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·February 7, 2024
Medline convenience kits: ACD DYNJ904999J ACDF DYNJ907336B DYNJ910821A ACDF PACK DYNJ81098C ACL DYNJ911996 ACL ACCESSORY PACK DYNJ86584B ACL- LF DYNJ905281B ACL PACK DYNJ67271A ALIF DYNJ904848L ANTERIOR CERVICAL DYNJ901355J ARTHROSCOPY DYNJ908193B ARTHROSCOPY PACK-LF DYNJ42963M DYNJ52268B ARTHROSCOPY SHOULDER DYNJ908684A BACK CDS-LF CDS983364G BACK PACK DYNJT4339 CDH SPINE PACK DYNJ908828D CERVICAL CDS DYNJ903477J CMC ORTHO BACK TRAY SYNJ10272B CRANIOTOMY DYNJ911853 CRANIOTOMY ROOSEVELT PACK DYNJ58358F CUSTOM HAND PACK-LF DYNJ0537135V CUSTOM SPINAL PACK DYNJT7544 DISCECTOMY PACK DYNJ86770 DJ ORTHO SPINE DYNJ48980M EXTREMITY PACK-LF DYNJT4161 FOOT PACK DYNJ53179D GENERAL ORTHO-ACNW DYNJ84891 GILMORE SHOULDER SCOPE PACK DYNJ58002 GV LUMBAR LAMINECTOMY PK DYNJ46938L HAND PACK DYNJ63113B DYNJ69662A DYNJT5855 HAND-LF DYNJ903263B KIT LAMINECTOMY DYNJ908806C KNEE ARTHROSCOPY DYNJ902056C DYNJ904846I KNEE ARTHROSCOPY-LF DYNJ905871F KNEE SCOPE DYNJ906986G LAMINECTOMY DYNJ904847K DYNJ909505D LAMINECTOMY CDS CDS983115K LAMINECTOMY CERVICAL DISC-LF DYNJ905286G LAMINECTOMY NEURO PACK DYNJ58356F LAMINECTOMY SPINE DYNJ904139L LOWER EXTREMITY PACK DYNJ63114C LUMBAR CERVICAL PACK-LF DYNJ0101088G LUMBAR LAMI DYNJ905020J LUMBAR LAMINECTOMY DYNJ53707 LUMBAR LAMINECTOMY PACK DYNJT4386 MAIN/LAMINECTOMY PACK-LF DYNJ0565499AN NJ SPINE SPECIALIST PACK DYNJ58706F OHOW SPINE-BACK PACK DYNJ910097A ORTHO NECK CDS-LF CDS983134C ORTHO PACK-LF DYNJ37202G ORTHO SPINE DYNJ40221G OSC BEACH CHAIR SHOULDER-LF DYNJ905282C PACC PETRIE ACL ADD ON PACK-LF DYNJ58290D PACK,ARTHROSCOPY ASC DYNJ65484A PACK,POSTERIOR SPINAL FUSION DYNJ906892B PAD LATERAL SPINE DYNJ902158L DYNJ902158M PAD POSTERIOR SPINE DYNJ902142L PK-SPINE DYNJ58259A PODIATRY PACK DYNJ62288D POST SPINE PACK DYNJ20509R POSTERIOR SPINAL FUSION DYNJ903250B RFT ARTHROSCOPY PACK DYNJ43956C RFT SHOULDER PACK-NOBLE DYNJ36331D SA SHOULDER #2 BORDEN DYNJ56501A SHOULDER DYNJ900893M DYNJ904184I SHOULDER ARTHROSCOPY DYNJ904842G SHOULDER PACK DYNJ83483 SHOULDER PACK-LF DYNJ42973N SHOULDER SCOPE PACK NTX DYNJ68399C SPINAL PACK DYNJ49692G SPINE DYNJ910451A SPINE PACK DYNJ20147O DYNJ84971 DYNJ86044A DYNJ86308C DYNJ88917 DYNJS3069 DYNJT4163 DYNJT8396 ST CHARLES TOTAL HIP DYNJ909593C TOTAL HIP DYNJ910906D TOTAL HIP PACK DYNJ64156B TOTAL JOINT DYNJ904186G TOTAL KNEE PACK DYNJ60967 DYNJ61409A WMC ORTHO SPINE WMC-LF DYNJ902528M XLIF DYNJ910795B
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·June 24, 2026
Medline Convenience kits labeled as: 1) PREP TRAY, Pack Number DYNDA1540; 2) STERILE PREP TRAY , Pack Number DYNDA2499; 3) ED PREP TRAY, Pack Number DYNDA2519; 4) ED PREP TRAY, Pack Number DYNDA2519H ; 5) PRE-OP PREP KIT , Pack Number DYNDA3076; 6) PILGRIM PREP TRAY , Pack Number DYNDC3282; 7) PILGRIM PREP TRAY , Pack Number DYNDC3282A ; 8) PILGRIM PREP TRAY , Pack Number DYNDC3282B ; 9) KYPHO PREP PACK-LF, Pack Number DYNJ0618280G ; 10) KYPHO PREP PACK-LF, Pack Number DYNJ0618280I ; 11) KYPHO PREP PACK-LF, Pack Number DYNJ0618280J ; 12) SPECIAL PROCEDURE PREP TRAY-LF, Pack Number DYNJ0738967A ; 13) BASIC SET UP PACK-LF, Pack Number DYNJ28988I ; 14) BASIC SET UP PACK-LF , Pack Number DYNJ28988I ; 15) VERTEBRALPLASTY PREP TRAY PACK, Pack Number DYNJ36311A ; 16) PK-SETUP PACK , Pack Number DYNJ43804A ; 17) SKIN LESION PACK, Pack Number DYNJ44258G ; 18) SETUP PACK, Pack Number DYNJ46187D ; 19) PK-SET UP -LF , Pack Number DYNJ53220B ; 20) IR PATIENT PREP KIT-LF, Pack Number DYNJ64857A ; 21) SKIN SCRUB PACK , Pack Number DYNJ68561; 22) DMEK PREP PACK, Pack Number DYNJ81659A ; 23) SET UP PACK , Pack Number DYNJ84247; 24) BASIC SET UP PACK-LF, Pack Number DYNJ85036; 25) SET UP CDS-ASC, Pack Number DYNJ900073C; 26) GENERAL SET UP, Pack Number DYNJ906282C; 27) JEWISH MAJOR SETUP, Pack Number DYNJ909261A; 28) SET UP, Pack Number DYNJ909403 ; 29) PREP TRAY , Pack Number DYNJRA1280A; 30) PREP TRAY , Pack Number DYNJRA1424 ; 31) NERVE BLOCK/W , Pack Number DYNJRA1424H; 32) PREP TRAY, Pack Number DYNJRA1498B; 33) PREP TRAY , Pack Number DYNJRA1583C; 34) PREP TRAY , Pack Number DYNJRA1760 ; 35) PREP TRAY , Pack Number DYNJRA1774 ; 36) PREP TRAY , Pack Number DYNJRA1783 ; 37) PREP TRAY , Pack Number DYNJRA1946A; 38) WINCHESTER PREP PACK-LF , Pack Number PHS627837003 ; 39) WINCHESTER PREP PACK-LF , Pack Number PHS627837003A
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024
Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C; 3) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158; 4) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170; 5) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170A; 6) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170B; 7) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182; 8) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182A; 9) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182B; 10) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183; 11) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183A; 12) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183B; 13) KIT STC FACIAL FRACTURE, Model Number: DYKMBNDL34A; 14) KIT SURG ONC MASTECTOMY A, Model Number: DYKMBNDL39; 15) KIT SURG ONC MASTECTOMY A, Model Number: DYKMBNDL39A; 16) KIT SURG ONC MASTECTOMY, Model Number: DYKMBNDL39C; 17) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL46; 18) KIT STC PLASTIC FREE FLAP, Model Number: DYKMBNDL54; 19) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69; 20) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69A; 21) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69B; 22) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78; 23) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78A; 24) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78B; 25) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84; 26) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84C; 27) MJR PLASTICS PK MV SURG CT-LF, Model Number: DYNJ0785310G; 28) ASC ENT PLASTIC PACK-LF, Model Number: DYNJ0854650J; 29) BREAST PACK ASC-LF, Model Number: DYNJ36469I; 30) ENT TYMPANOPLASTY PACK-LF, Model Number: DYNJ38988J; 31) DR WILDE BRSTMASS/PARTMAST-XM, Model Number: DYNJ39831F; 32) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852K; 33) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852M; 34) BREAST PACK, Model Number: DYNJ50957G; 35) PLASTICS BREAST PACK, Model Number: DYNJ55358G; 36) BHN IMPLANT PACK, Model Number: DYNJ56737A; 37) BREAST PACK, Model Number: DYNJ60210A; 38) PLASTICS PACK 2, Model Number: DYNJ64927F; 39) SPECIALTY FACIAL PLASTICS PACK, Model Number: DYNJ68844A; 40) BREAST IMPLANT PACK, Model Number: DYNJ69351; 41) BREAST/TUMMY PACK, Model Number: DYNJ83788; 42) HMSL PLASTICS, Model Number: DYNJ83884B; 43) CHEST/BREAST-LF, Model Number: DYNJ83950A; 44) CHEST/BREAST-LF, Model Number: DYNJ83950B; 45) FREE FLAP A DIRTY, Model Number: DYNJ86165; 46) MAJOR SURGERY PACK, Model Number: DYNJ86816; 47) BREAST REDUCTION PACK, Model Number: DYNJ87444; 48) OMF FREE FLAP, Model Number: DYNJ902005I; 49) BREAST CDS, Model Number: DYNJ902558G; 50) TRUNCAL CONTOURING, Model Number: DYNJ903555D; 51) TRUNCAL CONTOURING, Model Number: DYNJ903555F; 52) NEW TISSUE RETRIEVAL MH, Model Number: DYNJ903849C; 53) LARGE PROCEDURE-LF, Model Number: DYNJ907847A; 54) (34) STC FACIAL FRACTURE, Model Number: DYNJ907874A; 55) FACELIFT, Model Number: DYNJ910462; 56) MAJOR PLASTIC BREAST PACK-LF, Model Number: DYNJT3283; 57) MAJOR BREAST PACK-LF, Model Number: DYNJT3417; 58) PLASTICS PACK-LF, Model Number: PHS806973G
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·February 25, 2026
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINOPLASTY CDS d. ACH PLASTICS BREAST-LF e. NE BREAST RECON CDS f. PLASTIC SURGERY CDS g. MINOR PLASTIC CDS h. GROTH BREAST CDS i. BREAST ABD j. MINOR/U-BAR CDS-LF k. PLASTIC BREAST CDS-LF l. BREAST-HERNIA-PORT CDS-LF m. DAY SURG PLASTIC CDS n. PLASTIC SURGERY PACK o. PLASTIC PACK-LF p. PLASTIC-GENERAL SURGERY PACK q. PLASTIC PACK-LF r. ABDOMINOPLASTY/BREAST s. PLASTIC PACK t. BREAST PACK u. PLASTIC SURGERY TRAY v. BREAST AUGMENTATION PACK w. FACE PACK x. LIPOSUCTION PACK y. UNIVERSAL PLASTIC PACK z. PLASTIC PACK aa. LIPOSUCTION PACK bb. MINOR BREAST PACK cc. PLASTICS PACK-LF dd. UPPER PLASTIC PACK-LF ee. BREAST MAJOR PACK-LF ff. CAM PARTIAL MASTECTOMY PACK gg. PLASTIC PACK hh. BREAST PACK ii. BREAST RECONS COMBO PK XM-LF jj. PLASTICS PACK kk. BREAST REDUCTION PACK ll. BREAST HERNIA PK mm. T PLASTY PACK nn. ASC PLASTICS PACK oo. PLASTICS PACK-LF pp. OCULOPLASTIC PICK PACK qq. PLASTIC SURGERY LF PACK rr. PLASTIC PACK ss. OCULAR PLASTIC PACK tt. CHEST BREAST PACK uu. BREAST PACK vv. MAJOR PLASTIC PACK ww. FACIAL PLASTICS PACK xx. PLASTIC PACK yy. BREAST PACK zz. CHEST/BREAST PACK aaa. BREAST PACK bbb. BREAST PACK LJ-LF ccc. SCRIPPS SW PLASTIC PACK ddd. BREAST PACK eee. BREAST PACK fff. PLASTIC SURGERY U-BAR PACK ggg. PHOENIXVILLE BREAST PACK hhh. LAB PLASTIC PACK #DF2 iii. PLASTIC PACK jjj. GENERAL PLASTIC PACK kkk. CHEST/BREAST lll. MAJOR PLASTIC PACK mmm. MAJOR BREAST PACK nnn. BREAST ABDOMINOPLASTY PACK ooo. DR HOLCOMB FACIAL PACK ppp. MAJOR PLASTIC BREAST PACK qqq. DIAZ PACK rrr. BREAST PACK sss. BREAST PACK ttt. CHEST PACK uuu. PLASTIC FACIAL PACK vvv. FACIAL PLASTICS PACK www. BLEPHAROPLASTY PACK xxx. BREAST PACK - MOISES yyy. PLASTIC PACK zzz. PLASTIC PACK aaaa. BREAST AUGMENTATION PACK bbbb. CHEST/BREAST cccc. BREAST PACK dddd. PLASTIC PACK eeee. PLASTICS PACK ffff. PLASTIC PACK gggg. CHEST BREAST PACK hhhh. PLASTIC PACK iiii. CAROLINA FACIAL PLASTIC PACK jjjj. BREAST PACK kkkk. CHEST BREAST PACK llll. BREAST DBL PROCED SUPPLEMENT mmmm. BREAST PACK nnnn. PLASTIC PACK oooo. PLASTICS PACK pppp. ESC PLASTICS PACK qqqq. FACE LIFT PACK rrrr. CHEST BREAST ssss. BREAST PACK tttt. MINOR PLASTIC PACK uuuu. #2 FACIAL PLASTY PACK vvvv. BBL PACK wwww. BASIC PACK xxxx. BREAST PACK yyyy. BREAST AUGMENTATION PACK zzzz. BREAST PACK aaaaa. MAJOR BREAST OR UNIVERSAL bbbbb. CHEST/BREAST-LF ccccc. CUSTOM PLASTIC PACK ddddd. CHEST/BREAST PACK eeeee. PLASTIC GENERAL PACK fffff. SPECIALTY FACIAL PLASTICS PACK ggggg. OCCULOPLASTICS PACK hhhhh. BREAST PACK iiiii. LIPOSUCTION PACK jjjjj. BREAST PACK kkkkk. PLASTICS PACK lllll. BREAST PACK mmmmm. BREAST REDUCTION PACK nnnnn. BREAST AUGMENTATION PACK ooooo. FACE/RHINOPLASTY PACK ppppp. BREAST PACK qqqqq. TUMMY TUCK PACK rrrrr. BREAST PACK sssss. PLASTICS PACK ttttt. BREAST/ABDOMINAL PACK uuuuu. PLASTIC PACK vvvvv. BREAST PACK wwwww. RECONSTRUCTION PACK xxxxx. PLASTIC PACK yyyyy. PLASTICS PACK zzzzz. PLASTICS PACK aaaaaa. GENERAL PLASTIC-LF bbbbbb. PLASTIC UNIVERSAL cccccc. BREAST HA-LF dddddd. BREAST eeeeee. PLASTIC ffffff. BREAST gggggg. MAJOR BREAST hhhhhh. CHEST/BREAST-MRMCASU iiiiii. BREAST RECONSTRUCTION PACK jjjjjj. CHEST/BREAST kkkkkk. BREAST PACK llllll. BREAST BIOPSY/MASTECTOMY mmmmmm. CHEST/BREAST-LF
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023
Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number: DYNDH2104; 3) CARDIAC CATH PACK-LF, Model Number: DYNJT2164M; 4) ANGIOGRAPHY TRAY, Model Number: DYNJT3078; 5) CATH PACK, Model Number: DYNJT4190; 6) ANGIO VASCULAR PACK, Model Number: DYNJT5717; 7) HEART CATH PACK, Model Number: DYNJ0381139R; 8) CARDIAC CATH PACK, Model Number: DYNJ04529L; 9) CUSTOM RADIOLOGY PACK, Model Number: DYNJ07955L; 10) STVZ CARDIAC CATH PACK, Model Number: DYNJ24619J; 11) CATH TRAY #2, Model Number: DYNJ24706D; 12) CATH LAB PACK, Model Number: DYNJ24802Q; 13) CATH PACK, Model Number: DYNJ30268K; 14) HEART CATHETERIZATION PACK, Model Number: DYNJ30927R; 15) HEART CATH TRAY PACK-LF, Model Number: DYNJ31944D; 16) CATH PACK-LF, Model Number: DYNJ33061D; 17) CATH PACK, Model Number: DYNJ34638K; 18) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ38120C; 19) CATH PACK, Model Number: DYNJ40904G; 20) CARDIAC CATH-LF, Model Number: DYNJ41057D; 21) CATH LAB PACK, Model Number: DYNJ41172; 22) ANGIOGRAPHY PACK, Model Number: DYNJ42134G; 23) CATH LAB DRAPE PACK, Model Number: DYNJ42455B; 24) ANGIOGRAPHY PACK, Model Number: DYNJ42543B; 25) CATH LAB PACK, Model Number: DYNJ42900D; 26) ANGIOGRAPHY PACK NO SYR, Model Number: DYNJ43009K; 27) CATH PACK (WITH MANIFOLD), Model Number: DYNJ44515L; 28) ANGIO IR DRAPE PACK 319696, Model Number: DYNJ44593I; 29) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ44850J; 30) CATH LAB PACK, Model Number: DYNJ45296; 31) ANGIO PACK, Model Number: DYNJ50739J; 32) CARDIAC CATH PACK, Model Number: DYNJ51103F; 33) IR ANGIO BODY, Model Number: DYNJ51765D; 34) INTERVENTIONAL TRAY, Model Number: DYNJ52501C; 35) CARDIAC CATH IMF 86040- LF, Model Number: DYNJ53947J; 36) CARDIAC CATH PACK, Model Number: DYNJ54101I; 37) ANGIO KIT, Model Number: DYNJ55686C; 38) CATH LAB PACK, Model Number: DYNJ56141B; 39) ANGIO NEURO PACK, Model Number: DYNJ57685D; 40) CATH PACK, Model Number: DYNJ57729F; 41) CATH PACK, Model Number: DYNJ59632F; 42) CATH LAB PACK WITH NAMIC, Model Number: DYNJ60853D; 43) ANGIO PACK ALEX, Model Number: DYNJ63539C; 44) ANGIOGRAPHY CV RAD PACK, Model Number: DYNJ64936B; 45) CATH LAB PACK, Model Number: DYNJ65185D; 46) CATH PACK, Model Number: DYNJ65619A; 47) CATH I W SPLIT DRAPE PACK, Model Number: DYNJ66182; 48) CATH PACK SHD, Model Number: DYNJ68384B; 49) CATH LAB PACK, Model Number: DYNJ69094B; 50) CATH LAB ACCESSORIES, Model Number: DYNJ69213B; 51) REYES CATH PACK, Model Number: DYNJ69345A; 52) TMH ANGIOGRAPHY TRAY, Model Number: DYNJ80054A; 53) ANGIOGRAPHY TRAY, Model Number: DYNJ80156; 54) CATH PACK, Model Number: DYNJ80516C; 55) CATH PACK, Model Number: DYNJ80730; 56) ANGIO DRAPE PACK 2 WINDOW, Model Number: DYNJ81066B; 57) OR ANGIOGRAM PACK, Model Number: DYNJ81435F; 58) HEART CATH PACK, Model Number: DYNJ81527B; 59) HEART CATH PACK, Model Number: DYNJ83764D; 60) CATH LAB PACK, Model Number: DYNJ84048A; 61) ANGIO TRAY NO LIDO, Model Number: DYNJ85557B; 62) CARDIAC CATH PACK, Model Number: DYNJ85746B; 63) ANGIOGRAPHY PACK, Model Number: DYNJ86313; 64) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ86787; 65) CATH PACK, Model Number: DYNJ87098A; 66) CATH LAB TAVR PACK, Model Number: DYNJ88532; 67) SMT LEFT HEART CATH, Model Number: DYNJ89274; 68) VASCULAR CATH PACK, Model Number: DYNJ89352; 69) CATH LAB PACK, Model Number: DYNJ89805; 70) CARDIAC CATH MERCY WASHINGTON, Model Number: DYNJ89934; 71) ANGIO, Model Number: DYNJ900278G; 72) TAVR ICC VER. F, Model Number: DYNJ904401F; 73) TAVR, Model Number: DYNJ908646C; 74) LHK-UPMC CHILDRENS MAIN OR 2, Model Number: NAM0009; 75) KIT ANGIO CSTM-EVERGREEN, Model Number: NAM0020; 76) GP-CARDIAC CATH PACK-LF, Model Number: PHS397170009D; 77) LEFT HEART KIT - MARION, Model Number: VASC1073A; 78) RHK - VAMC RICHMOND, Model Number: VASC1185B; 79) LHK-MEADOWVIEW REG, Model Number: VASC1263; 80) LHK - BSC 3V ON S10RA, Model Number: VASC1269; 81) LHK - BSC 3V ON S10MLL, Model Number: VASC1270; 82
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·April 29, 2026
Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e. ZALE HEAD & NECK CDS f. CUH PARA/THYROIDECTOMY CDS g. CAM ENDOSCOPIC SINUS/SEPTO CDS h. HEAD AND NECK CDS i. HEAD AND NECK CDS-LF j. NASAL k. ENT SET UP CDS l. MINOR ENT SINUS PACK-LF m. MAJOR EAR PACK-LF n. THORACOTOMY HARPER PACK-LF o. FESS NSR PACK-LF p. ENT BASIC PACK-LF q. HEAD & NECK-LF r. ENT PACK-LF s. SINOSCOPY-LF t. MAJOR HEAD/NECK PACK-LF u. NECK PACK v. HEAD & NECK PACK w. HEAD & NECK TRAY x. ENT LAW PACK-LF y. ENT PACK z. NECK PACK aa. NASAL PACK bb. ENT PACK cc. FREE FLAP PACK-LF dd. TYMPANO MASTOID ee. MINOR HEAD & NECK #40-RF ff. EAR PACK gg. E.N.T. TRAY hh. EAR PACK-LF ii. BASIC ENT PACK-LF jj. PLASTIC HEAD & NECK PACK kk. EAR TRAY #10-RF ll. HEAD & NECK ENT PACK-RF-LF mm. ENT PACK nn. ENT PACK-LF oo. NASAL/SEPTO PACK pp. OSC FACE LIFT PK qq. RRMC NASAL PACK rr. ENT PACK ss. HENRYS ENT PACK tt. ENT uu. FACE AND NASAL PACK vv. NASAL PACK ww. ENT PACK xx. SINUS ENDOSCOPY-LF yy. OSC NASAL-NOSE PACK-LF zz. ENT PACK aaa. FES PACK - LF bbb. HEAD AND NECK PACK ccc. SCRIPPS SW ENT PACK ddd. SCRIPPS SW EAR PACK-LF eee. HL ENT PACK fff. CAROTID ENDARTECTOMY PK ggg. EAR PACK hhh. ENT FREE FLAP iii. HEAD AND NECK PACK jjj. TRACH PACK kkk. HL EAR PACK lll. NASAL SINUS ENDO PK mmm. ENT PACK nnn. HEAD AND NECK PACK ooo. ENT PACK ppp. HEAD AND NECK PACK qqq. ASC HEAD & NECK PACK rrr. ENT PACK sss. DEACONESS HEAD AND NECK PACK ttt. ENT PACK uuu. BEC MOHS PACK vvv. PK,ENT-EAR www. SVMMC HEAD AND NECK PACK xxx. PK, ENT yyy. HEAD AND NECK PACK zzz. FESS PACK aaaa. PK,ENT-SINUS bbbb. NASAL/HEAD & NECK PACK cccc. ENT PACK dddd. ENT PACK eeee. MAJOR ENT PACK ffff. ENT NECK MMC PACK gggg. HEAD AND NECK PACK hhhh. HEAD AND NECK PACK iiii. HEAD AND NECK PACK jjjj. ORAL PACK kkkk. HMT THORACOSCOPY PACK llll. GU PACK mmmm. HEAD NECKPACK (HNSJC)227-LF nnnn. HEAD AND NECK PLUS I PACK oooo. NASAL PACK pppp. HEAD & NECK PACK-RFD-LF qqqq. ENT PACK rrrr. ENT/H&N PACK ssss. C-SECTION PACK tttt. ENT PACK uuuu. ENT PACK vvvv. ENT PACK wwww. NASAL ENT PACK xxxx. SINUS PACK yyyy. HEAD/NECK PACK zzzz. ENT PACK aaaaa. NASAL PACK bbbbb. FESS PACK ccccc. NASAL SEPTOPLASTY PACK ddddd. ENT PACK eeeee. HEAD&NECK fffff. EAR PACK-LF ggggg. HEAD AND NECK PACK-LF hhhhh. EAR BASIC PACK iiiii. HEAD AND NECK PACK jjjjj. ENT/SEPTO PACK kkkkk. ENT PACK lllll. HEAD & NECK PACK mmmmm. HEAD AND NECK PACK nnnnn. ENT PACK ooooo. ENT PACK-LF ppppp. ENT PACK-LF qqqqq. HL DR PETERS ENT PACK rrrrr. RHINO/SEPTO/FESS PACK sssss. HEAD & NECK ttttt. THYROID/PARATHYROID PACK uuuuu. HEAD AND NECK MINOR PACK vvvvv. PK,ENT wwwww. ENT PACK xxxxx. ENT PACK yyyyy. ENT PACK zzzzz. ENT NECK PACK aaaaaa. ENT PACK bbbbbb. NECK PACK cccccc. EAR TRAY dddddd. HEAD & NECK PACK eeeeee. HEAD & NECK PACK ffffff. MHPB HEAD AND NECK PACK gggggg. NASAL PACK hhhhhh. ENT PACK iiiiii. JHOC EAR TRAY jjjjjj. JHOC HEAD TRAY kkkkkk. ENT I llllll. ENT SHARED mmmmmm. ENT PACK nnnnnn. EENT SPLIT PACK-NO GPAD oooooo. ENT PACK pppppp. HEAD & NECK PACK qqqqqq. NASAL PACK rrrrrr. ENT PACK ssssss. ENT PACK tttttt. ENT PACK uuuuuu. ENT PACK vvvvvv. ENT PACK-LF wwwwww. ENT I-LF xxxxxx. MAJOR HEAD AND NECK PACK yyyyyy. HEAD AND NECK PACK zzzzzz. FACE AND NECK aaaaaaa. ENT PACK bbbbbbb. ENT PACK ccccccc. ENT BASIC PACK-LF ddddddd. ENT PACK-LF eeeeeee. PK, ENT-H&N fffffff. ENT PACK ggggggg. SPRINGS HEAD AND NECK PACK hhhhhhh. ENDO SINUS PACK iiiiiii. HEAD/NECK PACK jjjjjjj. ENT/SINUS PACK-LF kkkkkkk. ENT PACK lllllll. NASAL PACK mmmmmmm. ENT PACK nnnnnnn. ORAL PLASTIC FACIAL PACK ooooooo. ENT HEAD NECK PACK ppppppp. THYROIDECTOMY PACK qqqqqqq. MINOR ORL PACK rrrrrrr. EAR CUSTOM PACK sssssss. MG NS ENT PACK ttttttt. HEAD AND NECK PACK uuuuuuu. ENT PACK vvvvvvv. MAJOR ENT PACK wwwwwww. ENT xxxxxxx. NASAL EAR yyyyyyy. NASAL-LF zzzzzzz. LARGE ENT aaaaaaaa. EAR bbbbbbbb. HEAD AND NECK cccccccc. PAD ENT HEAD & NECK dddddddd. FHT CVOR TAVR eeeeeeee. MODULE NASAL NATALIE ffffffff. ENT-LF gggggggg. HEA
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023
Medline procedural kits labeled as: 1) ALL DOC EYE PACK, Pack Number DYNJ51654A ; 2) ASC CATARACT PACK , Pack Number DYNJ0855117O ; 3) BAI , Pack Number DYNJ53847D ; 4) BASIC EYE PACK, Pack Number DYNJ83699A ; 5) BASIC EYE PACK, Pack Number DYNJ81805; 6) BASIC EYE PACK, Pack Number DYNJ83699A ; 7) BYERS CATARACT, Pack Number DYNJ67344; 8) BYERS CATARACT, Pack Number DYNJ67344H ; 9) CATARACT, Pack Number DYNJ44544B ; 10) CATARACT, Pack Number DYNJ54713C ; 11) CATARACT CDS , Pack Number CDS983804F ; 12) CATARACT CDS, Pack Number CDS983804F ; 13) CATARACT DR MALONE PACK , Pack Number DYNJ51590A ; 14) CATARACT DR MULROONEY PACK, Pack Number DYNJ51595A ; 15) CATARACT DR STEVENS PACK, Pack Number DYNJ51593C ; 16) CATARACT L J, Pack Number DYNJ40056A ; 17) CATARACT PACK, Pack Number CMPJ03235C ; 18) CATARACT PACK, Pack Number DYNJ80316A ; 19) CATARACT PACK, Pack Number VAL011CTASF; 20) CATARACT PACK , Pack Number CMPJ03235C ; 21) CATARACT PACK , Pack Number DYNJ31020K ; 22) CATARACT PACK , Pack Number DYNJ31020L ; 23) CATARACT PACK , Pack Number DYNJ54790D ; 24) CATARACT PACK , Pack Number DYNJ64962; 25) CATARACT PACK , Pack Number DYNJ80316; 26) CATARACT PACK , Pack Number DYNJ80316A ; 27) CATARACT PACK , Pack Number DYNJ80487A ; 28) CATARACT PACK , Pack Number DYNJ80487B ; 29) CATARACT PACK , Pack Number DYNJ80487C ; 30) CATARACT PACK , Pack Number DYNJ80487F ; 31) CATARACT PACK , Pack Number DYNJ84265A ; 32) CATARACT PACK , Pack Number DYNJ85332; 33) CATARACT PACK , Pack Number LYN042CPFEG; 34) CATARACT PACK , Pack Number VAL011CTASF; 35) CATARACT PACK , Pack Number DYNJ43048K ; 36) CATARACT PACK , Pack Number DYNJ52649D ; 37) CATARACT PACK , Pack Number DYNJ52649F ; 38) CATARACT PACK , Pack Number DYNJ55682D ; 39) CATARACT PACK , Pack Number DYNJ63284A ; 40) CATARACT PACK , Pack Number DYNJ63284B ; 41) CATARACT PACK , Pack Number DYNJ66410B ; 42) CATARACT PACK , Pack Number DYNJ85042; 43) CATARACT PACK , Pack Number DYNJ68836B ; 44) CATARACT PACK - GB, Pack Number DYNJ54790F ; 45) CATARACT PACK LUTHER HOSPITAL , Pack Number DYNJ61699D ; 46) CATARACT PACK WITH NO TUB , Pack Number DYNJ80232; 47) CATARACT PACK WITH NO TUB , Pack Number DYNJ80232H ; 48) CATARACT PACK-LF, Pack Number DYNJ42830D ; 49) CATARACT PACK-LF, Pack Number DYNJ0200004B ; 50) CATARACT PACK-LF, Pack Number DYNJ36100C ; 51) CATARACT TRAY , Pack Number DYNJ44356I ; 52) CATARACT TRAY , Pack Number DYNJ44356J ; 53) CATARACT TRAY , Pack Number DYNJ62410A ; 54) COVENANT RETINAL TRAY , Pack Number EYT102K; 55) CUSTOM EYE TRAY #1, Pack Number DYNJ66003D ; 56) CUSTOM EYE TRAY #1, Pack Number DYNJ66003C ; 57) CUSTOM EYE TRAY #1, Pack Number DYNJ66003D ; 58) CUSTOM EYE TRAY #2 , Pack Number DYNJ66004B ; 59) CUSTOM EYE TRAY #2, Pack Number DYNJ66004A ; 60) CUSTOM EYE TRAY #2, Pack Number DYNJ66004B ; 61) DDD VITRECTOMY PACK-LF, Pack Number DYNJ19973S ; 62) DR FLOOD EYE PACK , Pack Number DYNJ57258G ; 63) DR. OSTER GROSSER EYE PACK, Pack Number DYNJ44671C ; 64) DR. OSTER GROSSER EYE PACK, Pack Number DYNJ44671D ; 65) EYE , Pack Number DYNJ0559863K ; 66) EYE BCS PACK, Pack Number DYNJ37682J ; 67) EYE BCS PACK, Pack Number DYNJ37682K ; 68) EYE CATARACT (BASIC EYE), Pack Number DYNJ63272B ; 69) EYE INJECTION KIT , Pack Number MNS13080 ; 70) EYE MUSCLE PACK , Pack Number DYNJ66022A ; 71) EYE MUSCLE TRAY FFX , Pack Number DYNJ63638A ; 72) EYE PACK, Pack Number DYNJ40135C ; 73) EYE PACK, Pack Number DYNJ55484A ; 74) EYE PACK, Pack Number DYNJ60960A ; 75) EYE PACK, Pack Number DYNJ67973B ; 76) EYE PACK, Pack Number DYNJ83799C ; 77) EYE PACK, Pack Number VAL013EPWEC; 78) EYE PACK, Pack Number VAL038BSCLC; 79) EYE PACK, Pack Number DYNJ56293D ; 80) EYE PACK, Pack Number DYNJ64051C ; 81) EYE PACK, Pack Number CMPJ06528F ; 82) EYE PACK, Pack Number DYNJ38400I ; 83) EYE PACK, Pack Number DYNJ38400J ; 84) EYE PACK, Pack Number DYNJ64284C ; 85) EYE PACK, Pack Number DYNJ64284D ; 86) EYE PACK, Pack Numbe
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 4, 2024
Sterile Procedural Trays, labeled as the following: a. SPINAL b. SPINE CDS c. TOTAL ORTHO CDS d. TOTAL KNEE CDS e. CDS HIP-LF f. KNEE TOTAL PACK-LF g. EXTREMITY CDS h. SHOULDER ARTHRO CDS i. GLENNON EXTREMITY CDS j. KNEE ARTHROSCOPY k. TOTAL KNEE l. TOTAL HIP REPLACEMENT m. TOTAL KNEE CDS-LF n. TOTAL SHOULDER CDS-LF o. TOTAL KNEE CDS-3 p. TOTAL HIP CDS-3 q. LOWER EXTREMITY CDS-LF r. TOTAL HIP-LF s. TOTAL HIP/KNEE CDS t. SPINE PROCEDURE u. OPEN HEART v. LAMI w. UPPER EXTREMITY CDS x. LOWER EXTREMITY CDS y. KNEE ARTHROSCOPY CDS z. KNEE ARTHROSCOPY CDS-LF aa. SHOULDER CDS-LF bb. PODIATRY CDS cc. KNEE ARTHROSCOPY CDS dd. SHOULDER ARTHROSCOPY CDS ee. ACL CDS ff. CRANIOTOMY CDS gg. TOTAL KNEE CDS hh. TOTAL KNEE ii. TOTAL HIP CDS jj. NEW LONDON TOTAL KNEE CDS kk. TRAUMA CDS-LF ll. TOTAL JOINT CDS mm. CRANIOTOMY CDS-1 nn. SHOULDER CDS-1 oo. SPINE CDS-1 pp. TOTAL KNEE CDS-1 qq. TOTAL HIP CDS-1 rr. LOWER EXTREMITY CDS-2 ss. HAND CDS-2 tt. KNEE ARTHROSCOPY CDS-2 uu. HAND CDS vv. BACK CDS ww. FRACTURE TABLE CDS xx. ORTHO OP CDS yy. ARTHROSCOPY CDS zz. ORTHO MINOR CDS aaa. TOTAL JOINT KNEE CDS bbb. TOTAL JOINT HIP CDS ccc. SHOULDER CDS-LF ddd. ZALE CRANIOTOMY CDS eee. ZALE TOTAL KNEE CDS fff. ZALE EXTREMITY CDS ggg. OPEN SHOULDER CDS hhh. LOWER EXTREMITY CDS iii. FHT TOTAL HIP jjj. FHT TOTAL KNEE RPLCMNT kkk. TOTAL HIP CDS lll. TOTAL KNEE CDS mmm. CCOC ACL-LF nnn. CCOC SPINAL FUSION ooo. CCOC MAJOR EXTREMITY ppp. EXTREMITY CDS qqq. PODIATRY CDS rrr. SHOULDER CDS sss. DISTAL LEG CDS ttt. HIP NAILING CDS uuu. SHOULDER CDS vvv. TOTAL HIP CDS www. UPPER EXTREMITY CDS xxx. BASIC ORTHO CDS yyy. TOTAL HIP PROCEDURE zzz. TOTAL JOINT CDS-LF aaaa. SHOULDER CDS-LF bbbb. HAND CDS-LF cccc. KNEE ARTHROSCOPY CDS-LF dddd. TOTAL JOINT eeee. UPPER EXTREMITY CDS ffff. LOWER EXTREMITY CDS gggg. GENERAL ORTHO CDS hhhh. ARTHROSCOPY CDS iiii. KNEE ARTHROSCOPY CDS jjjj. SHOULDER ARTHROSCOPY CDS kkkk. KNEE ARTHROSCOPY CDS llll. TOTAL ORTHO CDS mmmm. GROTH LOWER EXTREMITY CDS nnnn. HIP TOTAL PACK-ANTERIOR oooo. PRAIRIE STAR SPINE CDS pppp. 4TH FLOOR SHOULDER ARTHROSCOPY qqqq. FOOT & ANKLE CDS-LF rrrr. LAMI MICRODISC-LF ssss. HIP PINNING CDS-LF tttt. KNEE ARTHROSCOPY CDS-LF uuuu. UPPER EXTREMITY CDS-LF vvvv. SPINE CDS-LF wwww. SPINE CDS-LF xxxx. LOWER EXTREMITY/ELBOW CDS yyyy. HAND CDS zzzz. KNEE ARTHROSCOPY CDS aaaaa. SPINE CDS bbbbb. TOTAL HIP CDS ccccc. KNEE ARTHROSCOPY CDS ddddd. HAND CDS eeeee. TOTAL KNEE CDS-LF fffff. SPINE MODULE CDS ggggg. UPPER EXTREMITY CDS-LF hhhhh. TOTAL JOINT CDS iiiii. TOTAL JOINT CDS jjjjj. ORTHO TRAUMA CDS kkkkk. ACF CDS lllll. CRANIOTOMY CDS mmmmm. TOTAL JOINT CDS nnnnn. ARTHROSCOPY CDS ooooo. EXTREMITY CDS ppppp. PODIATRY CDS qqqqq. LAMINECTOMY CDS rrrrr. EXTREMITY CDS sssss. TOTAL KNEE CDS ttttt. TOTAL HIP CDS uuuuu. TOTAL KNEE vvvvv. ANTERIOR HIP wwwww. HAND WRIST FOREARM xxxxx. LOWER EXTREMITY yyyyy. TOTAL HIP zzzzz. TOTAL KNEE aaaaaa. SHOULDER ARTHROSCOPY bbbbbb. SHOULDER ARTHROSCOPY PK cccccc. LUMBAR LAMINECTOMY PACK dddddd. CRANIOTOMY PACK-LF eeeeee. OPEN SHOULDER PACK-LF ffffff. TOTAL HIP PACK-LF gggggg. TOTAL KNEE PACK-LF hhhhhh. SHOULDER ARTHROSCOPY PACK-LF iiiiii. EXTREMITY PACK jjjjjj. CLOSED HEART PEDS PACK kkkkkk. ORTHO MINOR PACK-LF llllll. FRACTURE TABLE PACK-LF mmmmmm. HAND - EDOC PACK-LF nnnnnn. FOOT LV - EDOC PACK-LF oooooo. SHOULDER - EDOC PACK-LF pppppp. FOOT ANKLE PACK-LF qqqqqq. OPEN HEART TRAY rrrrrr. SHOULDER PACK-LF ssssss. ROCKVILLE ASC EXTREMITY PACK tttttt. NEURO SPINE DRH PACK-LF uuuuuu. DRH ORTHOPEDIC I AND D PACK-LF vvvvvv. KNEE ARTHROSCOPY MIOSH PACK-LF wwwwww. HAND AND FOOT PACK-LF xxxxxx. SPINE BUNDLE PACK yyyyyy. MINOR ORTHOPEDIC PACK-LF zzzzzz. FEM POP PACK-LF aaaaaaa. LAMINECTOMY PACK-LF bbbbbbb. CRANIOTOMY PACK-LF ccccccc. MAJOR ORTHO PACK-LF ddddddd. HAND WRIST PACK-LF eeeeeee. TOSH PODIATRY PACK-LF fffffff. TOTAL HIP ARTHROPLASTY PACK-LF ggggggg. TOSH UPPER EXTREM MIOSH PK-LF hhhhhhh. OPEN HEART CHILDRENS PACK-LF iiiiiii. CRANIOTOMY PACK-LF jjjjjjj. SPINE HARPER PACK-LF kkkkkkk. CRANIOTOMY
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023
Medline Convenience kits labeled as: 1) ARTHROGRAPHY DRAPE PACK , Pack Number 00-399027M ; 2) ARTHROSCOPY CDS , Pack Number CDS940242I ; 3) ARTHROSCOPY-LF, Pack Number CDS940859J ; 4) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS940869U ; 5) ARTHROSCOPY CDS , Pack Number CDS940960I ; 6) ARTHROSCOPY CDS , Pack Number CDS941059L ; 7) ARTHROSCOPY CDS , Pack Number CDS941062K ; 8) ARTHROSCOPY CDS , Pack Number CDS941110L ; 9) ARTHROSCOPY , Pack Number CDS980751I ; 10) ARTHROSCOPY CDS , Pack Number CDS980893; 11) SHOULDER ARTHROSCOPY CDS-LF , Pack Number CDS981003K ; 12) ARTHROSCOPY CDS , Pack Number CDS981011B ; 13) ARTHROSCOPY PROCEDURE , Pack Number CDS981660J ; 14) SHOULDER ARTHROSCOPY CDS, Pack Number CDS982199G ; 15) ARTHROSCOPY CDS , Pack Number CDS982216C ; 16) ARTHROSCOPY CDS-LF, Pack Number CDS982232F ; 17) ARMC ARTHROSCOPY CDS, Pack Number CDS982278K ; 18) ASC SHOULDER ARTHRO CDS SRM-LF, Pack Number CDS982536C ; 19) ARTHROSCOPY PACK, Pack Number CDS982560D ; 20) ARTHROSCOPY CDS , Pack Number CDS982645J ; 21) ARTHROSCOPY CDS-LF, Pack Number CDS982757D ; 22) ARTHROSCOPY CDS , Pack Number CDS983102F ; 23) ARTHROSCOPY CDS-LF, Pack Number CDS983257I ; 24) ARTHROSCOPY CDS , Pack Number CDS983299G ; 25) ARTHROSCOPY CDS , Pack Number CDS983414C ; 26) ARTHROSCOPY SHOULDER, Pack Number CDS983462I ; 27) ARTHROSCOPY CDS SC-LF , Pack Number CDS983740G ; 28) SHOULDER ARTHROTOMY CDS SC-LF , Pack Number CDS983744F ; 29) ARTHROSCOPY CDS , Pack Number CDS983918F ; 30) KNEE ARTHROSCOPY CDS, Pack Number CDS984220I ; 31) ARTHROSCOPY CDS-LF, Pack Number CDS984426G ; 32) ARTHROSCOPY CDS-LF, Pack Number CDS984455C ; 33) ARTHROSCOPY CDS , Pack Number CDS984609B ; 34) ARTHROSCOPY CDS , Pack Number CDS984636A ; 35) ARTHROSCOPY CDS , Pack Number CDS985095D ; 36) ARTHROSCOPY CDS , Pack Number CDS985208B ; 37) ARTHROSCOPY CDS-LF, Pack Number CDS985294A ; 38) ARTHROSCOPY KNEE, Pack Number CDS985508D ; 39) BIOPSY/ARTHROGRAM TRAY, Pack Number DYNDH1115; 40) ARTHROGRAM TRAY , Pack Number DYNDH1134; 41) ARTHROGRAM TRAY , Pack Number DYNDH1243; 42) ARTHROGRAM PACK , Pack Number DYNDH1322; 43) ARTHROGRAM TRAY , Pack Number DYNDH1347; 44) ARTHROGRAM TRAY , Pack Number DYNDH1349; 45) ARTHROGRAM PACK , Pack Number DYNDH1350; 46) BEACH CHAIR SHOULDER PACK-LF, Pack Number DYNJ00040K ; 47) ARTHROGRAM PACK-LF, Pack Number DYNJ0101275A ; 48) ARTHROSCOPY PACK-LF , Pack Number DYNJ0101722C ; 49) ARTHROSCOPY PACK-LF , Pack Number DYNJ0103045G ; 50) ARTHROSCOPY LV - EDOC PACK-LF , Pack Number DYNJ0111409L ; 51) ARTHROSCOPY PACK-LF , Pack Number DYNJ01114D ; 52) ARTHROSCOPY II PACK-LF, Pack Number DYNJ0161097B ; 53) ARTHROSCOPY PACK, Pack Number DYNJ01829F ; 54) ARTHROSCOPY PACK-LF , Pack Number DYNJ0190768L ; 55) ARTHROSCOPY PACK-LF , Pack Number DYNJ0200295Q ; 56) ARTHROSCOPY PACK-LF , Pack Number DYNJ0219853Q ; 57) YUMH/SURGI-CENTER ARTHRO PK-LF, Pack Number DYNJ0244761K ; 58) ARTHRO KNEE PACK, Pack Number DYNJ02579F ; 59) ARTHROSCOPY PACK-LF , Pack Number DYNJ0281409O ; 60) PPSC ARTHROSCOPY PACK-LF, Pack Number DYNJ0303231D ; 61) ARTHROSCOPY PACK-LF , Pack Number DYNJ0365867L ; 62) ARTHROSCOPY PACK-LF , Pack Number DYNJ0366488I ; 63) ARTHROSCOPY PACK-LF , Pack Number DYNJ0373216K ; 64) ARTHROSCOPY PACK-LF , Pack Number DYNJ0373876F ; 65) ARTHROSCOPY PACK-LF , Pack Number DYNJ0374577N ; 66) ARTHROSCOPY PACK-LF , Pack Number DYNJ0376528J ; 67) ARTHROSCOPY PACK-LF , Pack Number DYNJ0377096D ; 68) ARTHROSCOPY PACK-LF , Pack Number DYNJ0378266K ; 69) ARTHROSCOPY PACK-LF , Pack Number DYNJ0382618L ; 70) ARTHROSCOPY PACK-LF , Pack Number DYNJ0390808F ; 71) ARTHROSCOPY PACK-LF , Pack Number DYNJ0399877G ; 72) ARTHROSCOPY PACK-LF , Pack Number DYNJ0406086L ; 73) ARTHROSCOPY PACK-LF , Pack Number DYNJ0410034P ; 74) GYN RESECTOSCOPE PACK-LF, Pack Number DYNJ0415339I ; 75) ARTHROSCOPY PROCEDURE PACK-LF , Pack Number DYNJ0415915I ; 76) ARTHROSCOPY PACK, Pack Number DYNJ04159A ; 77) ARTHROSCOPY PACK-LF , Pa
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024