MEDTRONIC PERFUSION TUBING PACKS — Class II medical device recall Z-2736-2015
Terminated recall by Medtronic Perfusion Systems, reported 2015-09-16, distributed nationwide. Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is below product s
| Recall number | Z-2736-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Perfusion Systems, Brooklyn Park, MN, United States |
| Recall initiated | 2015-08-18 |
| Classified | 2015-09-04 |
| Reported by FDA | 2015-09-16 |
| Terminated | 2016-05-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | BO, DK, DO, IT, LB, LV, MX, PA, SG, VE |
| Model numbers | 6B65R3, 6N21R2, 7U65R2, 8C72R4, BB5J59R19, BB7M38R11, BB7M38RLL, BB8N86R4, HY2U43R9, HY8R55R, HY8R66R3, M074704B, M230002A, M394415A, M450013B, M650123A, M971406C, TL2Q68R17, TL7M46R7 |
Product
MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model # 7U65R2, 8C72R4, 6N21R2, BB7M38R11, TL2Q68R17, HY8R66R3, HY2U43R9, 8C72R4, BB5J59R19, 6B65R3, TL7M46R7, TL2Q68R17, 7U65R2, M074704B, M230002A, BB7M38Rll, M450013B, BB8N86R4, HY2U43R9, 8C72R4, M650123A, HY8R55R ,TL7M46R7, M971406C, M450013B, 7U65R2, M394415A, M450013B. Enables the perfusionist to manage the patient's hematocrit and fluid status.
Reason for recall
Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is below product specification. These potentially affected units have been distributed as stand-alone devices and in specific lots of Medtronic Perfusion Tubing packs.
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-2736-2015. 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.