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    BD BBL BCYE Selective Agar with PAV, Catalog # 297880, packaged in cartons of 10 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualitative procedures for isolation of Legionella species from clinical specimen and nonclinical (environmental) samples. It is similar to the Edelstein formula, except that the concentration of polymyxin B is reduced by half, and vancomycin is substituted for cefamandole.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·July 31, 2013

    Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: 8065000093 Software Version: N/A Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·August 28, 2024

    SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space. Sets are intended for use with Sapphire Infusion Systems.

    FDA Enforcement
    Class II ·Terminated·ICU Medical Inc·December 26, 2018

    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case

    FDA Enforcement
    Class II ·Terminated·ICU Medical Inc·October 23, 2019

    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV 123 inch. 1 unit per pouch; 50 pouches per case

    FDA Enforcement
    Class II ·Terminated·ICU Medical Inc·October 23, 2019

    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case

    FDA Enforcement
    Class II ·Terminated·ICU Medical Inc·October 23, 2019

    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, 122 Inch. 1 unit per pouch; 50 pouches per case

    FDA Enforcement
    Class II ·Terminated·ICU Medical Inc·October 23, 2019

    Product Name: 25+ TTL PLUS VPAK 20000CPM BWV Model/Catalog Number: 8065830077 Software Version: N/A Product Description: Standardized assemblage of components, which includes the valved trocar entry system, that interface with the CONSTELLATION Vision System. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·August 28, 2024

    BBL Campylobacter CSM Agar (Charcoal-Based Selective Medium), Catalog # 299614, packaged in cartons of 20 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualitative procedures for isolation of Legionella species from clinical specimen and nonclinical (environmental) samples. It is similar to the Edelstein formula, except that the concentration of polymyxin B is reduced by half, and vancomycin is substituted for cefamandole.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·July 31, 2013

    Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·July 16, 2025

    CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093; 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000095; 27+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000096; 23GA BEVEL ULTRAVIT 10,000 CPM/ 8065752413; 25+ BEVEL ULTRAVIT 10,000 CPM/ 8065752415; 27+ BEVEL ULTRAVIT 10,000 CPM/ 8065752417; TOTAL PLUS,23G,10K VALVE STD/ 8065752435; TOTAL PLUS,23GA,10K VALVE WD/ 8065752436; TOTAL PLUS,25+,10K VALVE STD/ 8065752437; TOTAL PLUS,25+,10K VALVE WD/ 8065752438; TOTAL PLUS,27+,10K VALVE STD/ 8065752439; 23G CMB PAK 10K CPM,V,STD 0.9/ 8065752448; 23G CMB PAK 10K CPM,V,WA 0.9/ 8065752449; 25+ CMB PAK 10K CPM,V,STD 0.9/ 8065752450; 25+ CMB PAK 10K CPM,V,WA 0.9/ 8065752451; 27+ CMB PAK 10K CPM,V,STD 0.9/ 8065752452; 25+TTLPL VPK 20000CPM BEV VAL/ 8065753106; 27+TTLPL VPK 20000CPM BEV VL/ 8065753109; HYPERVIT 25+BEV 20000 CPM/ 8065830026; HYPERVIT 27+BEV 20000 CPM/ 8065830027; 25+ TTL PLUS VPAK 20000CPM BWV/ 8065830077; 25G VIT 25G OPTICARE EYE HLTH CTR/ 10924-15; VITRECTOMY 25G NORTHSIDE HOSP/ 11220-25; VITRECTOMY 25G NORTHSIDE HOSP/ 11220-27; 23G CONSTELLATION NORTHERN MICH SPPLY AL/ 12568-09; AUS-25GA VIT RET BRISBANE WATERS/ 12641-13; AUS-25GA VIT RET BRISBANE WATERS/ 12641-14; AUS-23GA 10K COMBINED VR PAK NEW CHILDRE/ 12852-16; 23G VIT CONSTELLATION LOMA LINDA COMM HO/ 13501-08; 25+G 20K VIT CONSTELLATION LOMA LINDA CO/ 13502-10; 23G VIT CONSTELLATION VALVED BAYSTATE ME/ 13591-13; 25G CONSTELLATION VALVED BAYSTATE MEDICA/ 13592-15; VITRECTOMY 25G V A HOSPITAL/ 14129-10; J-COMB PAK - 25G 20K CVS NAKAGAMI HOSPIT/ 14283-12; CDN-CVS VIT 25G VE 10K TIMMINS DH/ 14501-09; CDN-CVS VIT 25G+ VE 10K CIUSSS MCQ/ 14512-09; CDN-CVS VIT 25G+ VE 10K CIUSSS MCQ/ 14512-10; CDN-CVS VIT 23G 10K WA SASKATOON HR/ 14532-06; CDN-CVS VIT 23G 10K WA SASKATOON HR/ 14532-07; CDN-CVS VIT 10K 25G+ HSC, ST JOHN'S/ 14540-08; CDN-CVS COMBO 23G VE 10K HD KINGSTON/ 14541-16; CDN-CVS VIT 25G+ 20K BV JEWISH GH/ 14597-07; CDN-CVS VIT 23G 10K ROCKYVIEW HOSPITAL/ 14603-15; CDN-CVS COMBO 25G VE 10K TIMMINS DH/ 14669-10; CDN-CVS COMBO 25G VE 10K TIMMINS DH/ 14669-11; CDN-CVS VIT 23G VE ROYAL ALEXANDRA HOSP/ 14671-09; CDN-CVS VIT 25G+ 10K ROCKYVIEW HOSPITAL/ 14672-11; CDN-CVS VIT 25G+ BWV 20K CUSM/MUHC/ 14873-06; CDN-CVS VIT 25G+ BWV 20K CUSM-MUHC/ 14873-07; CDN-VIT 23G VE 10K ST MICHAEL'S HOSP/ 14955-08; CDN-VIT 23G VE 10K ST MICHAELS HOSP/ 14955-09; CDN-CVS 25G+ VIT VE 10K ST MICHAEL'S/ 14956-07; CDN-CVS 25G+ VIT VE 10K ST MICHAELS/ 14956-08; CDN-CVS VIT 25G+ 10K WESTERN MH/ 15006-06; CDN-CVS VIT 25G+ 20K WA WESTERN MH/ 15006-07; CDN-CVS COMBO 23G 10K ROCKYVIEW HOSPITAL/ 15108-09; CDN-CVS CMB 25G+ V 10K OAKVILLE-TRAFALGA/ 15167-08; 25G PLUS VITRECTOMY PEACE HEALTH ST JOSE/ 15223-13; CDN-VIT 23G 10K GRM741746 CUO-HSS/ 15294-14; CDN-COMBO 23G 10K GRM741759 CUO-HSS/ 15295-12; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-05; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-06; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-07; CDN-CVS COMBO 23G V 10K ST MICHAEL'S HSP/ 15324-07; CDN-COMBO 25G 20K GRM743287 CUO-HSS/ 15421-13; CDN-COMBO 25G 20K GRM743287 CUO-HSS/ 15421-14; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-08; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-09; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-10; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-04; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-05; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-06; CDN-CVS 23G COMBO VE 10K SUNNYBROOK GH/ 15464-05; CDN-CVS 23G VIT VE 10K SUNNYBROOK GH/ 15465-05; 23G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15491-05; 23G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15491-06; 27G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15492-02; 27G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15492-03; 25G+ VIT PACK CALLAHAN EYE FOUNDATION HO/ 15493-05; 25G+ VIT PACK CALLAHAN EYE FOUNDATION HO/ 15493-06; CDN-CVS VIT 25G+ 10K PASQUA HOSPITAL/ 15525-04; CDN-CVS COMBO 23G VE 10K KENSINGTON EI/ 15552-05; CDN-CVS 23G VIT VE 10K KENSINGTON EYE IN/ 1

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·December 3, 2025

    Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·July 16, 2025

    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

    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. AAA PACK, Model Number: DYNJ44847I; b. ABDOMINAL VASCULAR PACK, Model Number: DYNJ82578; c. ABDOMINAL VASCULAR-LF, Model Numbers: DYNJ905291B, DYNJ905291C; d. ABLATION PACK, Model Number: DYNJ61957A; e. ACCESSORY OPEN HEART PACK, Model Number: DYNJ36600F; f. ADULT CORONARY PACK, Model Numbers: DYNJV0275J, DYNJV0275K, DYNJV0275L, DYNJV0275M; g. AFIB PACK, Model Number: DYNJ69682; h. ALT MINOR VASCULAR CDS, Model Number: CDS840493F; i. ANGIO-VASCULAR, Model Number: DYNJ24272C; j. ARM VASCULAR-LF, Model Number: DYNJ905290D; k. ARTERIAL/VENOUS ACCESS TRAY, Model Number: DYNDC3038; l. ARTERIOGRAM PACK, Model Numbers: DYNJ81636, DYNJ81636A; m. ARTERIOGRAM PACK 2, Model Number: DYNJ83051; n. AUD MAJOR VASC PK-LF, Model Number: DYNJ40728D; o. AUD MAJOR VASCULAR-LF, Model Number: DYNJ40728A, DYNJ40728B, DYNJ40728C; p. AV FIST PACK, Model Number: DYNJ83462; q. AV FISTULA, Model Numbers: DYNJ64143B, DYNJ905219B, DYNJ905219C, DYNJ905219D; DYNJ905219F, DYNJ906341D, DYNJ906945A, DYNJ907975, DYNJ907975B, DYNJ908096; r. AV FISTULA CAROTID PACK, Model Number: DYNJ82570; s. AV FISTULA PACK, Model Number: DYNJ52093J, DYNJ62218B, DYNJ66184A, DYNJ66184B, DYNJ67178A, DYNJ69443A, DYNJ69443B, DYNJ69443D, DYNJ69489A, DYNJ81033, DYNJ81605, DYNJ82477; t. AV FISTULA PACK-LF, Model Number: DYNJ64499B, DYNJ64499D, DYNJ69167A, DYNJ69167C; u. AV FISTULA VASCULAR, Model Number: DYNJ67340; v. AV GRAFT, Model Number: DYNJ903457D; w. AV GRAFT-LF, Model Number: DYNJ40077F; x. BAPTIST SOUTH OPEN HEART CV PK, Model Number: CDS983147F, CDS983147I; y. BEDSIDE PICC CDS, Model Number: CDS984642; z. BGMC CAROTID MAJOR VASCULAR, Model Number: DYNJ907339; aa. C V MAJOR PACK, Model Number: DYNJ64861A; bb. C V MINOR PACK, Model Number: DYNJ64862B; cc. CABG, Model Numbers: DYNJ906878A, DYNJ9372030F, DYNJ9372030G; dd. CABG HEART CDS, Model Number: CDS985384C; ee. CABG PACK, Model Numbers: DYNJ0408782AA, DYNJ53827, DYNJ59036B, DYNJ59036C, DYNJ59036D, DYNJ59036F; ff. CABG PACK NTX, Model Numbers: DYNJ68389, DYNJ68389A; gg. CARDIAC A B PACK-LF, Model Number: DYNJV0177AG; hh. CARDIAC A & B PACK-LF, Model Number: DYNJV0177AG; ii. CARDIAC CABG B, Model Numbers: DYNJ908121A, DYNJ908121B; jj. CARDIAC CABG PACK, Model Number: DYNJ903072R; kk. CARDIAC CATH PACK, Model Number: DYNJ41195D; ll. CARDIAC EP PACK-LF, Model Numbers: DYNJ0429185K, DYNJ0429185M; mm. CARDIAC ROBOT PACK, Model Number: DYNJ66254A; nn. CARDIOLOGY EP, Model Number: DYNJ59968; oo. CARDIOVASCULAR PT 2, Model Numbers: DYNJ905516C, DYNJ905516D, DYNJ905516F; pp. CAROTID DR WILLIAMS, Model Numbers: DYNJ906351B, DYNJ906351D; qq. CAROTID ENDARTERECTOMY, Model Number: DYNJ905640A; rr. CAROTID PACK, Model Numbers: DYNJ0810062AI, DYNJ0810062AJ, DYNJ39488G, DYNJ66190A, DYNJ66190B, DYNJ66190C, DYNJ80346A; ss. CAROTID PACK-LF, Model Number: DYNJ57646C; tt. CAROTID SUPPLY PACK, Model Number: DYNJ81369; uu. CAROTID VASCULAR PACK, Model Number: DYNJ44927F; vv. CAROTID-LF, Model Number: CDS984764F, DYNJ901745K; ww. CATH LAB PACK, Model Number: DYNJ57735F; xx. CATH PACK, Model Number: DYNJ59830A; yy. CLOVIS CATH LAB PACK, Model Number: DYNJ62379A; zz. CT CABG-LF - IFCAP 7279, Model Number: DYNJC9258G; aaa. CUH OPEN HEART A B C - CDS, Model Number: CDS983202F, CDS983202G, CDS983202I; bbb. CUSTOM CARDIAC CABG, Model Number: DYNJ906108A, DYNJ906108B, DYNJ906108C; ccc. CV AAA PACK W AUX, Model Number: DYNJ65710A; ddd. CV CDS, Model Number: CDS985395D; eee. CVOR ANGIOGRAPHY PACK, Model Number: DYNJ83432; fff. CVOR ENDOVASCULAR PACK, Model Number: DYNJ64506A; ggg. CVP PACK, Model Numbers: DYNJ46359C, DYNJ46359D; hhh. DBD-ABDOMINAL VASCULAR-LF, Model Number: DYNJ905291C; iii. DBD-ALT MINOR VASCULAR CDS, Model Number: CDS840493F; jjj. DBD-ALT MINOR VASCULAR CDS, Model Number: CDS840493F; kkk. DBD-AV FISTUL

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 9, 2023