medical Class II Updated 2022-01-19

Medtronic Perfusion Systems recalls Medtronic Custom Perfusion kits, with the following product

Recalled Product

Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R FILTER (Model BB10Q85R); 2. CUSTOM PACK BB11C01R MIDI DEEP (Model BB11C01R); 3. CUSTOM PACK BB7H95R22 HYP MAIN (Model B7H95R22); 4. CUSTOM PACK BB7H95R25 HYP MAIN (Model BB7H95R25); 5. CUSTOM PACK BB7H99R22 NEONAT (Model BB7H99R22); 6. CUSTOM PACK BB7P46R4 316-14 (Model BB7P46R4); 7. CUSTOM PACK BB7P48R4 14-38 (Model BB7P48R4); 8. CUSTOM PACK BB7W03R8 CCSM NEON (Model BB7W03R8); 9. CUSTOM PACK BB7W80R7 BASC PEDS (Model BB7W80R7); 10. CUSTOM PACK BB8B09R7 INFANT (Model BB8B09R7); 11. CUSTOM PACK BB8B09R8 INFANT (Model BB8B09R8); 12. CUSTOM PACK BB8D40R3 P3/16X1/4 (Model BB8D40R3); 13. CUSTOM PACK BB8Q16R PED ART (Model BB8Q16R); 14. CUSTOM PACK BB8V01R8 FVDL COLM (Model BB8V01R8); 15. CUSTOM PACK HY2V10R33 ADULT (Model HY2V10R33); 16. CUSTOM PACK HY3Z71R17 PRIMARY (Model HY3Z71R17); 17. CUSTOM PACK HY3Z71R18 PRIMARY (Model HY3Z71R18); 18. CUSTOM PACK HY4V00R24 ADULT (Model HY4V00R24); 19. CUSTOM PACK HY6X29R12 CON-SUPP (Model HY6X29R12); 20. CUSTOM PACK HY8L14R7 HYBRID (Model HY8L14R7); 21. CUSTOM PACK HY8P36R6 CPS (Model HY8P36R6); 22. CUSTOM PACK HY8V01R6 FVDL COLM (Model HY8V01R6); 23. CUSTOM PACK HY9D36R1 HL PUMP P (Model HY9D36R1); 24. CUSTOM PACK HY9L07R4 ADLT FUS (Model HY9L07R4); 25. CUSTOM PACK HY9L80R4 SADT FUS (Model HY9L80R4); 26. CUSTOM PACK HY9M47R6 ADLT MAIN (Model HY9M47R6); 27. CUSTOM PACK HY9N38R4 VGH FUS (Model HY9N38R4); 28. CUSTOM PACK HY9R26R12 CENT (Model HY9R26R12); 29. PERFUSION M337112Q 1/B (Model M337112Q); 30. PERFUSION M344130B 1/B (Model M344130B); 31. PERFUSION M392419C 1/B (Model M392419C); 32. PERFUSION M394213B 1/B (Model M394213B); 33. PERFUSION M394213C 1/B (Model M394213C); 34. PERFUSION M490124D 1/B (Model M490124D); 35. PERFUSION M491335A 1/B (Model M491335A); 36. PERFUSION M499709E 1/B (Model M499709E); 37. PERFUSION M960164F 1/B (Model M960164F); 38. PERFUSION M960165E 1/B (Model M960165E); 39. PERFUSION M960169E 1/B (Model M960169E); 40. PERFUSION M960462C 1/B (Model M960462C); 41. PERFUSION M960462D 1/B (Model M960462D); 42. PERFUSION M960463D 1/B (Model M960463D); 43. PERFUSION M960466D 1/B (Model M960466D); 44. CUSTOM PACK TL4K33R3 FCI ADULT (Model TL4K33R3); 45. CUSTOM PACK TL4K95R12 PERFNPLEG (Model TL4K95R12); 46. CUSTOM PACK TL6C91R5 SELLKE PK (Model TL6C91R5); 47. CUSTOM PACK TL6G48R9 ST PAULS (Model TL6G48R9); 48. CUSTOM PACK TL7X09R3 FCVC ADLT (Model TL7X09R3);

Hazard / Issue

Product is labeled as non-pyrogenic but endotoxin testing was not performed.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Medtronic Perfusion Kits: 1. Model BB10Q85R, (a) GTIN 00763000343057, Lot Numbers: 219164410, 220219784, 220822136, 222227252; (b) GTIN 20763000343068, Lot Numbers: 219822381, 220104257 2. Model BB11C01R, GTIN 00763000312190, Lot Numbers: 218556144, 218790882, 219012584, 219586019 3. Model B7H95R22, GTIN 00763000250904, Lot Numbers: 219586008, 220075503, 220476338 4. Model BB7H95R25, GTIN 00763000451738, Lot Numbers: 221406421 5. Model BB7H99R22, GTIN 00763000250911, Lot Numbers: 219814395, 219886115, 220143946, 220257643, 220434398 6. Model BB7P46R4, GTIN 00643169380967, Lot Numbers: 218503747, 219975261, 220383910, 221017404, 221148797 7. Model BB7P48R4, GTIN 00643169379848, Lot Numbers: 219073386 8. Model BB7W03R8, GTIN 00643169990562, Lot Numbers: 219107651, 219491297, 221590546 9. Model BB7W80R7, GTIN 00763000344535, Lot Numbers: 219380830, 219600017, 222304697, 222400044 10. Model BB8B09R7, GTIN 00763000307189, Lot Numbers: 218613111 11. Model BB8B09R8, GTIN 00763000347574, Lot Numbers: 219291877, 219529760, 219663957, 220095395, 220476333, 221148863, 221765951, 222227240, 222469109 12. Model BB8D40R3, GTIN 00643169655461, Lot Numbers: 219220652, 219482298 13. Model BB8Q16R, GTIN 00643169549364, Lot Numbers: 218657286, 221451556 14. Model BB8V01R8, GTIN 00763000411312, Lot Numbers: 221267645 15. Model HY2V10R33, GTIN 00763000299835, Lot Numbers: 219165752, 220104314 16. Model HY3Z71R17, GTIN 00763000241551, Lot Numbers: 219073460 17. Model HY3Z71R18, GTIN 00763000353728, Lot Numbers: 219435852, 220219913, 220911962 18. Model HY4V00R24, GTIN 00763000082451, Lot Numbers: 219115980, 219436006, 219975242, 220383867 19. Model HY6X29R12, GTIN 00763000280833, Lot Numbers: 218912023, 219061258, 219061259, 219061260, 219390708, 220075525, 220075526, 220281424, 220434431 20. Model HY8L14R7, GTIN 00763000353360, Lot Numbers: 220075494 21. Model HY8P36R6, GTIN 00763000097165. Lot Numbers: 219291532 22. Model HY8V01R6, GTIN 00763000025465, Lot Numbers: 218557263, 218901885 23. Model HY9D36R1, GTIN 00643169855465, Lot Numbers: 219291881, 219291882, 219291883, 219682010, 220144062, 220144063, 220383952, 220383953, 220383954 24. Model HY9L07R4, GTIN 00763000093495, Lot Numbers: 219237962 25. Model HY9L80R4, GTIN 00763000092603, Lot Numbers: 220104289 26. Model HY9M47R6, GTIN 00763000175634, Lot Numbers: 219165837, 219165838, 219452417, 219452418, 220295056, 220295059 27. Model HY9N38R4, GTIN 00643169985148, Lot Numbers: 219061189, 219390629, 220383876, 220954138 28. Model HY9R26R12, GTIN 00763000317942, Lot Numbers: 218790663, 219343932, 219401495, 220337254, 220866450, 220866451 29. Model M337112Q, GTIN 00763000242824, Lot Numbers: 219983643, 219984266, 221053657, 221206757, 221452447, 221516971 30. Model M344130B, GTIN 00643169946415, Lot Numbers: 218419494, 218419495, 220815603, 220883905, 221971754 31. Model M392419C, GTIN 00763000343095, Lot Numbers: 219179139, 220224289, 220637117, 221383886 32. Model M394213B, GTIN 00643169546417, Lot Numbers: 218544365, 218544407 33. Model M394213C, GTIN 00763000446437, Lot Numbers: 221309293, 222084799 34. Model M490124D, GTIN 00763000527471, Lot Numbers: 222060635 35. Model M491335A, GTIN 00763000372187, Lot Numbers: 219712665, 220479358 36. Model M499709E, GTIN 00643169713420, Lot Numbers: 219495811 37. Model M960164F, GTIN 00763000300128, Lot Numbers: 218616224, 218616225, 219868444, 22280711 38. Model M960165E, GTIN 00763000139445, Lot Numbers: 218551983, 218728458, 218728459, 222107381 39. Model M960169E, GTIN 00763000139421, Lot Numbers: 218517966, 220900240, 222047414, 222410763 40. Model M960462C, GTIN 00643169957015, Lot Numbers: 218953465 41. Model M960462D, GTIN 00763000399344, Lot Numbers: 220172291 42. Model M960463D, GTIN 00763000234775. Lot Numbers: 218483662, 218517778, 218742946, 218742949, 220729353, 220801827, 220867180, 220950181, 221143520, 221618074, 221875985 43. Model M960466D, GTIN 00763000090494, Lot Numbers: 219874178 44. Model TL4K33R3, GTIN 00613994288622, Lot Numbers: 220197637 45. Model TL4K95R12, GTIN 00763000247867, Lot Numbers: 219061229, 220383926 46. Model TL6C91R5, GTIN 00643169343641, Lot Numbers: 219435870 47. Model TL6G48R9, GTIN 00763000367909, Lot Numbers: 220004241, 220004242, 220326313, 220911952, 220911998 48. Model TL7X09R3, GTIN 00643169455115, Lot Numbers: 219107641, 219107642, 221000547

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