9 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF 60010468; 2) MTS,RIGHT HEART,KIT,W/TRANS,ST. *, REF 60010511; 3) MTS,LT,HT,KIT-BRYAN,LGH,M.C.,EAST, REF 60020323; 4) MTO,RIGHT,KIT-BRONSON,M* HOSP PG, REF 60020676; 5) MTS,LEFT HEART,KIT-C*,MEM HLTHCARE, REF 60035977; 6) MTS,LEFT HEART,KIT,J*,M*,C*, REF 60040273; 7) MTS,LEFT HEART,KIT,C*,C*, REF 60100313; 8) MTS,3V,KIT-M*,MEMORIAL, REF 60131208; 9) MTS,3V,KIT-M*,MEMORIAL, REF 60131208; 10) MTO,LEFT HEART,KIT,-,N* HOSPITAL PG, REF 60140101; 11) MTO,LEFT HEART,KIT,-,N* HOSPITAL PG, REF 60140101; 12) MTS,LEFT HEART,MAN,KIT,S*-BALTIMORE, REF 60190947; 13) MTS-LEFT HEART,KIT-W*,H* HOSP PG, REF 60231052; 14) MTO,3-VALVE,KIT-T*,A*-PG, REF 65190182; 15) MTO,LEFT HEART,KIT,-,S* F*,-,PG, REF 65190474; 16) MTS,DR.,MCKAYS,4V,KIT,-,H* HOSP PG, REF 600800516; 17) MTS,EP,KIT,-,S*,TEACHING HOSPITAL PG, REF 601309013; 18) MTS,RHT,HRT-S* HOSP &,MC, REF 601905413; 19) MTS,PEDS,LFT,&,RT,HRT-S* HOSP, REF 601905414; 20) MTO,SCH,BEL,J*,H*-ST-PAUL,-,PG, REF 606604328; 21) LHK,-,MID,3VCOMP,OFF,PS,S10RA, REF 613000122; 22) MTS,LHK,W* HOSPITAL, REF 6010034281; 23) MTS,LHK,W* HOSPITAL, REF 6010034281; 24) MTS,LHK,P*,P* MED CTR, REF 6010171931; 25) MTS,LHK,M* HEALTHCARE,MGMT, REF 6061073001; 26) TVR US B* INTEGRATED SERVICE CENT, REF 601316711A; 27) LHK-S* MEDICAL CENTER,A*, REF 60190776A; 28) LHK,-,S*,AND,W* HOSPITAL, REF 60191118A.
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 2, 2025
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. HEAD AND NECK CDS-LF, Medline SKU # CDS780138K; 2. HEART CATH PACK-LF, Medline SKU # DYNJ36478B; 3. HEART CATH PACK-LF, Medline SKU # DYNJ36478B; 4. HEART CATH PACK-LF, Medline SKU # DYNJ36478B; 5. THYROIDECTOMY, Medline SKU # DYNJ910458; 6. LH 3 PORT W/O WASTEBAG, Medline SKU # VASC1081C; 7. LHK, Medline SKU # VASC1510; 8. LHK, Medline SKU # VASC1510.
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·April 15, 2026
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. MTS RH LFT HRT KIT, Medline SKU # 60010508; 2. MTS 3V W/GUIDE, Medline SKU # 60100701; 3. ANGIOGRAPHY KIT, Medline SKU # 60131209; 4. MTS LHK, Medline SKU # 60160075; 5. MTS LHK, Medline SKU # 60161954; 6. MTO LHK, Medline SKU # 60230148; 7. GENERAL SURGERY TRAY, Medline SKU # 00-500510I; 8. BIOBURDEN TEST KIT - 686, Medline SKU # BIOB686; 9. RADIO ANGIO UNIV HOSP PACK-LF, Medline SKU # DYNJ0376145M; 10. SPECIALS PACK-LF, Medline SKU # DYNJ0392706K; 11. CARDIAC CATH PACK-LF, Medline SKU # DYNJ0451426O; 12. CARDIAC CATH PACK-LF, Medline SKU # DYNJ0451426P; 13. CARDIAC CATH PACK, Medline SKU # DYNJ07953N; 14. CATH PACK-LF, Medline SKU # DYNJ0803367J; 15. E.P. TRAY, Medline SKU # DYNJ19343J; 16. CARDIAC CATH PACK, Medline SKU # DYNJ20898T; 17. CATH LAB TRAY, Medline SKU # DYNJ24250G; 18. CATH LAB PACK-LF, Medline SKU # DYNJ38333D; 19. CATH LAB PACK-LF, Medline SKU # DYNJ38333F; 20. EP IMPLANT PACK-LF, Medline SKU # DYNJ38910D; 21. ADULT CATH LAB PACK, Medline SKU # DYNJ40380J; 22. CRANIOTOMY PACK-LF, Medline SKU # DYNJ43403D; 23. LAP CHOLE PACK, Medline SKU # DYNJ48487F; 24. CATH LAB ANGIOGRAPHY PACK, Medline SKU # DYNJ50779G; 25. CATH LAB ANGIOGRAPHY PACK, Medline SKU # DYNJ50779I; 26. HYBRID, Medline SKU # DYNJ57049N; 27. SPECIALS PK, Medline SKU # DYNJ57713C; 28. SPECIALS PK, Medline SKU # DYNJ57713D; 29. SPECIALS PK, Medline SKU # DYNJ57713F; 30. CARDIAC CATH LAB, Medline SKU # DYNJ57748A; 31. TAVR PACK, Medline SKU # DYNJ58771G; 32. CATH PACK GWV, Medline SKU # DYNJ59229F; 33. HEART CATH PACK, Medline SKU # DYNJ61294F; 34. CATH LAB PACK, Medline SKU # DYNJ61353C; 35. DEVICE IMPLANT PACK, Medline SKU # DYNJ64636A; 36. CUSTOM PROCEDURE KIT, Medline SKU # DYNJ65277A; 37. GENERAL VASCULAR PACK RFID-V2, Medline SKU # DYNJ66442F; 38. CARDIAC CATH PACK, Medline SKU # DYNJ69845C; 39. OMF MINOR PACK, Medline SKU # DYNJ83991C; 40. HEART CATH PACK, Medline SKU # DYNJ84133B; 41. SPECIAL PROCEDURES, Medline SKU # DYNJ85425B; 42. PRIMARY PACK, Medline SKU # DYNJT3093; 43. CARDIAC CATH PACK, Medline SKU # DYNJT3522A; 44. CARDIAC CATH PACK, Medline SKU # DYNJT3522B; 45. TOTAL KNEE PACK, Medline SKU # DYNJT4069; 46. CARDIAC CATH PACK, Medline SKU # DYNJT5685; 47. CATH PACK, Medline SKU # DYNJT6544; 48. PACK CARDIAC CATH, Medline SKU # DYNJT7591; 49. OBL CATH VEIN PACK, Medline SKU # DYNJT7863; 50. TUMESCENT SYRINGE KIT, Medline SKU # DYNJTUMSYR; 51. CSTM LH KIT, Medline SKU # VASC1054; 52. LHK, Medline SKU # VASC1130A; 53. MANIFOLD KIT, Medline SKU # VASC1137A; 54. LHK, Medline SKU # VASC1299A; 55. LHK, Medline SKU # VASC1399B; 56. LHK, Medline SKU # VASC1403; 57. IR 2 PORT, Medline SKU # VASC1404; 58. LHK, Medline SKU # VASC1405; 59. LHK, Medline SKU # VASC1455A; 60. TWO PORT MANIFOLD KIT, Medline SKU # VASC1496; 61. RHK, US, NAMIC MANIFOLD, Medline SKU # VASC1502; 62. LHK, Medline SKU # VASC1555; 63. 4 VALVE,PERC,MANIFOLD,KIT, Medline SKU # VASC1609; 64. LHK, Medline SKU # VASC1668; 65. LHK, Medline SKU # VASC1694; 66. LHK, Medline SKU # VASC1805; 67. TVR, Medline SKU # VASC1816.
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·April 15, 2026
TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.
FDA Enforcement
Class II
·Ongoing·B. Braun Medical, Inc.·November 15, 2023
Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model Number: 60022026; 3) MTO LEFT HEART KIT SUMMA BARBERT, Model Number: 60022673; 4) MTS LH KIT-UNIV OF MIAMI PG, Model Number: 60030817; 5) MTS LEFT HEART KIT SPRINGFIELD R, Model Number: 60031245; 6) MTS PERIPHERAL KIT SPRINGFIELD R, Model Number: 60031247; 7) MTS LEFT HEART KIT-COLISEUM MED, Model Number: 60031928; 8) MTS LEFT HEART KIT -2-CALIFORNIA, Model Number: 60033011; 9) MTS LEFT HEART KIT JOHN MUIR CON, Model Number: 60040273; 10) MTS EP MANIFOLD KIT TEXAS HLTH P, Model Number: 60041268; 11) MTS 3V MANIFOLD KIT-SPARROW HOSP, Model Number: 60050097; 12) MTS LEFT HEART KIT FORT SANDERS, Model Number: 60060387; 13) MTS LEFT HEART KIT-GOOD SAMARITA, Model Number: 60070435; 14) DBD-MTS ANGIO KIT-MOUNT HOOD MED, Model Number: 60070521; 15) MTS LFT HRT KIT-GRAND VIEW PG, Model Number: 60071743; 16) MTS CUSTOM MANIFOLD KIT-INGALLS, Model Number: 60090078; 17) MTS CATH LAB KIT - HEARTLAND PG, Model Number: 60090542; 18) MTS LEFT HEART KIT-W.C.A PG, Model Number: 60100071; 19) MTS MANIFOLD KIT-GENESYS REG MED, Model Number: 60100254; 20) MTS 4V W/PRO STA-ST.JOHNS REG ME, Model Number: 60100439; 21) MTS LEFT HEART KIT JEANES HOSPIT, Model Number: 60101773; 22) MTS LEFT HEART KIT-ST. MARYS OF, Model Number: 60131099; 23) DBD-MTS LEFT HEART KIT-LEHIGH VA, Model Number: 60132653; 24) MTS LEFT HEART KIT (3V DT WASTE), Model Number: 60138326; 25) MTS LF HRT KIT-PRESBYTERIAN UNIV, Model Number: 60160148; 26) MTS LEFT HEART KIT-PENINSULA REG, Model Number: 60160428; 27) MTS LEFT HEART KIT BARNES ST.PET, Model Number: 60161135; 28) MTO OR ENDO KIT - PARK RIDGE HOS, Model Number: 60163618; 29) MTS 3V W/DT-CORPUS CHRISTI M.C., Model Number: 60181531; 30) MTS 3V PERC MANIFOLD KIT WEST. A, Model Number: 60182137; 31) MTO CATH KIT PAMPA REGIONAL MED, Model Number: 60182661; 32) MTO HOPKINS LEFT HEART HOWARD CO, Model Number: 60183662; 33) MTS-CARDIOLOGY KIT-HARLINGEN MED, Model Number: 60184001; 34) MTS PERCEPTOR KIT METHODIST. RIC, Model Number: 60185432; 35) MTS LEFT HEART KIT SADDLEBACK ME, Model Number: 60191312; 36) MTS-CARD MAN KIT MARIAN MED CENT, Model Number: 60194273; 37) LEFT HEART KIT SOUTHERN HILLS HO, Model Number: 60195202; 38) MTS DR KHAIRALLAH LEFT HEART KIT, Model Number: 60200189; 39) MTS,4V,DIAG,KIT UNIV OF CONNECTICUT, Model Number: 60210014; 40) MTO L/H KIT-UNIV OF CLEVELAND -, Model Number: 60210047; 41) MTS LEFT HEART KIT-BAPTIST HLTH, Model Number: 60230503; 42) MTS CAN KIT ACCESSOIRE DIAGNOSTI, Model Number: 60700527; 43) MTS LEFT HEART W/SYRINGE-EMORY U, Model Number: 600503712; 44) MTS ACCESSORY KIT SAINT JOSEPH L, Model Number: 601010412; 45) MTS 3 PORT WHITE KIT LEESBURG RE, Model Number: 601222712; 46) MTS PEDS LFT RT HRT-SUNRISE HO, Model Number: 601905414; 47) MTS LHK ST. LOUIS CARDIO INST, Model Number: 606119072; 48) LHK CENTURA HLTH CORP (ST. ANTHO, Model Number: 6010030361; 49) MTS LHK CHAMPLAIN VALLEY, Model Number: 6010128411; 50) MTS LHK VANDERBILT COFFEE HARTON, Model Number: 6019705921; 51) DBD-LHK EPIC SURGERY CENTER LLC, Model Number: 6020410581; 52) DBD-MTS LHK MS HEALTHCARE MGMT, Model Number: 6061073001; 53) LHK - WESLEY MEDICAL CENTER, Model Number: 6010088152A; 54) IR ANGIOGRAPHY PACK-LF, Model Number: DYNJVB1077D; 55) RADIOLOGY SPECIALS TRAY, Model Number: DYNJVB1302B; 56) ANGIO LEFT HEART PACK, Model Number: DYNJ40632D; 57) ANGIO RIGHT HEART PACK, Model Number: DYNJ40633C; 58) ANGIO TRAY, Model Number: DYNJ43278C; 59) CARDIAC LEG PACK, Model Number: DYNJ44065C; 60) EP PACK, Model Number: DYNJ55512A; 61) VASCULAR PACK, Model Number: DYNJ58522A; 62) PERIPHERAL CATH, Model Number: DYNJ59220C; 63) CARDIAC CATH - NO SYR, Model Number: DYNJ62409A; 64) C V MINOR PACK, Model Number: DYNJ64862B; 65) ENDOVASCULAR PACK, Model Number: DYNJ65926
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·April 29, 2026
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075; 3. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636N; 4. CATH LAB TRAY, Medline Kit Number/SKU DYNJ24250G; 5. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333D; 6. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333F; 7. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779G; 8. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779I; 9. CLOT RETRIEVAL PACK, Medline Kit Number/SKU DYNJ56140C; 10. TAVR PACK NO SYR, Medline Kit Number/SKU DYNJ62310C; 11. TAVR PACK, Medline Kit Number/SKU DYNJ62310D; 12. TAVR PACK, Medline Kit Number/SKU DYNJ62310F; 13. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911; 14. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911A; 15. CATH PACK, Medline Kit Number/SKU DYNJT6544; 16. LHK, Medline Kit Number/SKU NAM0015; 17. SLU LHK, Medline Kit Number/SKU SAMPC0706.
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·May 20, 2026
Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDA3188; 3) VA ORLANDO SHOULDER PACK, Model Number: DYNJG001027B; 4) TUMESCENT SYRINGE KIT, Model Number: DYNJTUMSYR; 5) OMC PTCA PACK, Model Number: DYNJT3719; 6) PORT PACK, Model Number: DYNJT5667; 7) WASTE MANAGEMENT KIT - 2, Model Number: DYNJWASTEKIT2; 8) CARDIAC CATH, Model Number: DYNJ20175J; 9) D&C PACK-POB, Model Number: DYNJ33521D; 10) BASIC PACK, Model Number: DYNJ38533F; 11) CATH PACK IMPLANT, Model Number: DYNJ39230D; 12) CERVICAL SPINE PACK, Model Number: DYNJ40886B; 13) MV-IR ANGIO DRAPE PACK-LF, Model Number: DYNJ41553F; 14) TV ENDOVASCULAR-LF, Model Number: DYNJ41558D; 15) MAJOR PACK-LF, Model Number: DYNJ44816J; 16) ANGIOGRAPHY PACK, Model Number: DYNJ48683A; 17) EXTREMITY PACK, Model Number: DYNJ55922C; 18) NEURO PACK, Model Number: DYNJ57785C; 19) PACEMAKER PACK, Model Number: DYNJ61377B; 20) VASCULAR PACK, Model Number: DYNJ62683D; 21) LINQ INSERTION PK W/OUT LIDO, Model Number: DYNJ63668B; 22) BASIC PACK, Model Number: DYNJ83324; 23) OMF MINOR PACK, Model Number: DYNJ83991B; 24) ARTERIOGRAM SUMMIT PACK, Model Number: DYNJ84040B; 25) HMWB NEURO NAMIC PACK, Model Number: DYNJ86600; 26) VCH CARDIAC CATH PACK, Model Number: DYNJ89064; 27) RADIOLOGY PACK, Model Number: DYNJ89080; 28) LITHOTOMY PACK, Model Number: DYNJ89959; 29) AHT SPINE PACK, Model Number: DYNJ903566D; 30) LAP, Model Number: DYNJ904576B; 31) EP MERCY JANESVILLE, Model Number: DYNJ907013; 32) LHK, US, RUBY MEMORIAL HOSP, Model Number: NAM0032; 33) CHERIAN CATH KIT, Model Number: VASC1086; 34) RIGHT HEART KIT - LAKE NONA, Model Number: VASC1120; 35) KIT ANGIO CSTM-SHAWNEE, Model Number: VASC1151; 36) LEFT HEART KIT - OAKBEND, Model Number: VASC1155; 37) IR 2 PORT-ARROWHEAD REGIONAL, Model Number: VASC1404; 38) LHK - ARROWHEAD REGIONAL MED, Model Number: VASC1405; 39) LHK - UMC DOUBLE TRANSDUCER, Model Number: VASC1415A; 40) SDMC, EP TWO PORT CUSTOM KIT, Model Number: VASC1533; 41) ARTERIOGRAM TRAY, Model Number: 00-402001V
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·April 29, 2026
1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,KIT, Medline Kit Number/SKU 60033123; 3. MTS,3 VALVE,KIT, Medline Kit Number/SKU 60050183; 4. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60080349; 5. MTS,3 VALVE,LEFT HEART,KIT, Medline Kit Number/SKU 60100338; 6. MTS LHK, Medline Kit Number/SKU 60101017; 7. DBD-MTS,3 VALVE,KIT, Medline Kit Number/SKU 60130506; 8. MTS,LEFT,HRT,KIT, Medline Kit Number/SKU 60131324; 9. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60132238; 10. MTS,3,PORT,KIT, Medline Kit Number/SKU 60138301; 11. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60140589; 12. MTS,3 VALVE,W/, Medline Kit Number/SKU 60192012; 13. DBD-MTS,4V,MANIFOLD,KIT, Medline Kit Number/SKU 60220488; 14. MTS,LHK, Medline Kit Number/SKU 60232091; 15. MTO,3 VALVE,MANIFOLD,KIT, Medline Kit Number/SKU 65010037; 16. MTO,LEFT HEART,KIT, Medline Kit Number/SKU 65012819; 17. DBD-MTO,2V,LEFT HEART,KIT, Medline Kit Number/SKU 65040421; 18. DBD-MTO,LEFT HEART,KIT, Medline Kit Number/SKU 65183482; 19. MTS KIM, Medline Kit Number/SKU 65660872; 20. LHK,-, Medline Kit Number/SKU 601006269; 21. DBD-MTS,MANIFOLD,KIT, Medline Kit Number/SKU 601203616; 22. MTO,4V,KIT, Medline Kit Number/SKU 650104611; 23. MTO,MANIFOLD,KIT, Medline Kit Number/SKU 651304116; 24. KIMAL 3 PORT RH OFF WITH CC PG, Medline Kit Number/SKU 656206837; 25. KIM MANIFOLD SET VER ONE - PG, Medline Kit Number/SKU 656608724; 26. CARDIAC MAN PG, Medline Kit Number/SKU 656608737; 27. MTO MANIFOLD, Medline Kit Number/SKU 656608739; 28. CARDIAC MANIFOLD SET, Medline Kit Number/SKU 656608749; 29. CARDIAC MAN SET, Medline Kit Number/SKU 656608753; 30. KIMAL 3 PORT MAN KIT, Medline Kit Number/SKU 656608755; 31. DBD-MTS,LHK, Medline Kit Number/SKU 6010236231; 32. LHK, Medline Kit Number/SKU 6561068101; 33. LHK, Medline Kit Number/SKU 60022681B; 34. CARDIAC CATH PACK-LF, Medline Kit Number/SKU DYNJ0376288O; 35. CARDIAC CATH PACK-LF, Medline Kit Number/SKU DYNJ0376288P; 36. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636M; 37. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ0771922AA; 38. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ0771922Y; 39. CATH PACK, Medline Kit Number/SKU DYNJ21810L; 40. CATH PACK, Medline Kit Number/SKU DYNJ21810M; 41. CATH PACK, Medline Kit Number/SKU DYNJ21810N; 42. CARDIAC CATH PACK W/ADD ON, Medline Kit Number/SKU DYNJ22553F; 43. CATH LAB TRAY, Medline Kit Number/SKU DYNJ24250F; 44. HEART CATH, Medline Kit Number/SKU DYNJ27274J; 45. HEART CATH, Medline Kit Number/SKU DYNJ27274K; 46. HEART CATH, Medline Kit Number/SKU DYNJ27274L; 47. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ32376G; 48. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ32376I; 49. CATH/ANGIO PACK, Medline Kit Number/SKU DYNJ38087G; 50. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333C; 51. CATH PACK, Medline Kit Number/SKU DYNJ44473C; 52. CATH PACK, Medline Kit Number/SKU DYNJ44473D; 53. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779F; 54. ANGIO DRAPE CARDIAC PACK, Medline Kit Number/SKU DYNJ51615N; 55. ANGIO DRAPE CARDIAC PACK, Medline Kit Number/SKU DYNJ51615O; 56. ANGIO DRAPE CARDIAC PACK, Medline Kit Number/SKU DYNJ51615Q; 57. CARDIAC CATH IMF 86040- LF, Medline Kit Number/SKU DYNJ53947I; 58. CARDIAC CATH IMF 86040- LF, Medline Kit Number/SKU DYNJ53947J; 59. CARDIAC CATH LAB, Medline Kit Number/SKU DYNJ57748B; 60. PK CUST CATH LAB, Medline Kit Number/SKU DYNJ60584F; 61. PK CUST CATH LAB, Medline Kit Number/SKU DYNJ60584G; 62. PK CUST CATH LAB, Medline Kit Number/SKU DYNJ60584I; 63. HEART ABLATION DRAPE PACK, Medline Kit Number/SKU DYNJ61984B; 64. ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ64525B; 65. HMSL ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ64525C; 66. CATH LAB PACK, Medline Kit Number/SKU DYNJ64548D; 67. CATH LAB PACK, Medline Kit Number/SKU DYNJ64548F; 68. CATH LAB & E. P. PACK, Medline Kit Number/SKU DYNJ646
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·May 20, 2026
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