Data Foundry

Medical device recalls 2022

Medtronic Custom Perfusion kits — Class II medical device recall Z-0491-2022

Ongoing recall by Medtronic Perfusion Systems, reported 2022-01-19, distributed nationwide. Product is labeled as non-pyrogenic but endotoxin testing was not performed.

Recall numberZ-0491-2022
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMedtronic Perfusion Systems, Brooklyn Park, MN, United States
Recall initiated2021-10-12
Classified2022-01-12
Reported by FDA2022-01-19
DistributedNationwide (US)
Countries outside the USCA, DE, ES, FR, IT, NL, SA
Quantity6,653 units
Reason classeslabeling, sterility
UPC / GTIN / UDI-DI00613994288622, 00643169343641, 00643169379848, 00643169380967, 00643169455115, 00643169546417, 00643169549364, 00643169655461, 00643169713420, 00643169855465, 00643169946415, 00643169957015, 00643169985148, 00643169990562, 00763000025465, 00763000082451, 00763000090494, 00763000092603, 00763000093495, 00763000097165, 00763000139421, 00763000139445, 00763000175634, 00763000234775, 00763000241551 and 24 more
Lot numbers218419494, 218419495, 218483662, 218503747, 218517778, 218517966, 218544365, 218544407, 218551983, 218556144, 218557263, 218613111, 218616224, 218616225, 218657286, 218728458, 218728459, 218742946, 218742949, 218790663, 218790882, 218901885, 218912023, 218953465, 219012584, 219061189, 219061229, 219061258, 219061259, 219061260, 219073386, 219073460, 219107641, 219107642, 219107651, 219115980, 219164410, 219165752, 219165837, 219165838 and 118 more
Model numbersB7H95R22, BB10Q85R, BB11C01R, BB7H95R25, BB7H99R22, BB7P46R4, BB7P48R4, BB7W03R8, BB7W80R7, BB8B09R7, BB8B09R8, BB8D40R3, BB8Q16R, BB8V01R8, HY2V10R33, HY3Z71R17, HY3Z71R18, HY4V00R24, HY6X29R12, HY8L14R7, HY8P36R6, HY8V01R6, HY9D36R1, HY9L07R4, HY9L80R4 and 23 more

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);

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0491-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.