Custom Pack Perfusion Tubing Packs containing Affinity Fusion… — Class II medical device recall Z-1028-2023
Ongoing recall by Medtronic Perfusion Systems, reported 2023-02-08, distributed nationwide. An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusio
| Recall number | Z-1028-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Perfusion Systems, Brooklyn Park, MN, United States |
| Recall initiated | 2022-12-12 |
| Classified | 2023-01-27 |
| Reported by FDA | 2023-02-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BO, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, ES, FI, FR, GB, GH, GR, GT, HN, HR, HU, ID, IL, IR, IS, IT, JM, JO, JP, KE, KR, KW, LT, LU, LV, MX, MY, NG, NL, NO, NZ, OM, PH, PK, PL, PT, PY, RO, SA, SE, SI, TH, TR, TT, TW, UY, VN, ZA |
| Quantity | 40,498 units |
| UPC / GTIN / UDI-DI | 00643169505322, 00643169572263, 00643169618312, 00643169661295, 00643169713406, 00643169724310, 00643169771260, 00643169792180, 00643169930162, 00643169946392, 00643169949768, 00643169976412, 00763000021252, 00763000050559, 00763000060763, 00763000075866, 00763000077747, 00763000112042, 00763000140991, 00763000142995, 00763000174651, 00763000175726, 00763000187880, 00763000197445, 00763000211271 and 156 more |
| Lot numbers | 0076300022897, 222860769, 222860771, 222860780, 222875738, 222941490, 222941586, 222974885, 222974886, 223014639, 223014659, 223014660, 223014664, 223014736, 223066095, 223112640, 223145744, 223145745, 223173677, 223196543, 223196553, 223196617, 223196618, 223196717, 223206899, 223206900, 223234995, 223234999, 223235005, 223251170, 223258277, 223278252, 223283017, 223283018, 223283019, 223283250, 223283254, 223283258, 223300938, 223310002 and 460 more |
| Model numbers | 00643169505322, 00643169572263, 00643169618312, 00643169661295, 00643169713406, 00643169724310, 00643169771260, 00643169792180, 00643169930162, 00643169946392, 00643169949768, 00643169976412, 00763000021252, 00763000050559, 00763000060763, 00763000075866, 00763000077747, 00763000112042, 00763000140991, 00763000142995, 00763000174651, 00763000175726, 00763000187880, 00763000197445, 00763000211271 and 475 more |
Product
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in Cardiopulmonary bypass.
Reason for recall
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.
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-1028-2023. 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.