FDA Device recall Z-0826-2017
Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubing Packs The Affini…
- FDA Device
- Class II
- terminated
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class II recall of Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubing Packs The Affini… by Medtronic, citing medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion¿ Oxygenators with Balance¿1 Biosurface. These are distributed as stand-alone dev….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0826-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-16 |
| Published | 2016-12-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic |
| Distribution | US |
Product
Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubing Packs The Affinity Fusion Oxygenator with Integrated Arterial Filter with or without the Cardiotomy/Venous Reservoir with Balance¿1 Biosurface is intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
Reason
Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion¿ Oxygenators with Balance¿1 Biosurface. These are distributed as stand-alone devices, or as a combination unit with the Affinity Fusion Cardiotomy/Venous Reservoir, or as part of tubing packs. Medtronic has identified an out-of-specification condition exhibiting additional plastic (flash) in the arterial sampling port adjacent to the arterial outlet port of the oxygenator.
Identifiers
| code_info | Product UPN/GTIN Lot Number Product Number 00643169650749 212028376 HY8N22R8 00643169802421 211984809 BB9D23R3 00643…Product UPN/GTIN Lot Number Product Number 00643169650749 212028376 HY8N22R8 00643169802421 211984809 BB9D23R3 00643169707801 211991294 BB1D41R27 00643169871908 212073806 HY8B75R12 00643169621473 211950617 BB8U95R1 00643169860322 211865249 BB8E47R15 00643169865365 211975385 BB9D32R2 00643169860322 211991184 BB8E47R15 00643169717336 211991250 BB8Q09R2 00643169792852 211991385 BB9G59R5 00643169740020 211991295 HY8C67R10 00643169649101 211991248 BB7H73R14 00643169868120 212028234 BB8G43R3 00643169860322 212028305 BB8E47R15 00643169873032 212034498 HY9L88R2 00643169534629 212109150 BB7Z44R6 00643169591738 211846477 BB1A19R44 00643169786790 211991196 BB8X02R7 00643169639058 211846421 BB8N94R4 00643169649767 211991286 HY8J73R6 00643169869783 211991482 BB9E16R4 00643169861534 211914227 SSHY9M26R 00643169869516 211974259 BB9L66R 00643169872127 212020797 BB9L72R1 00643169736283 212028295 BB8S37R11 00643169776807 212028317 BB7X32R12 00643169546431 212028362 BB8C09R4 0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0826-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.