FDA Device recall Z-1028-2023
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811
- FDA Device
- Class II
- ongoing
- Published 2023-02-08
On 2023-02-08 the FDA classified a Class II recall of Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811 by Medtronic Perfusion Systems, citing 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-pr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1028-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-12 |
| Published | 2023-02-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Perfusion Systems |
| Distribution | US |
Product
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in Cardiopulmonary bypass.
Reason
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.
Identifiers
| code_info | Oxygenator Model CB811; Serial Number Range: 8111483548 - 8113999999; GTIN Number, Tubing Pack Model Number (Lot Number…Oxygenator Model CB811; Serial Number Range: 8111483548 - 8113999999; GTIN Number, Tubing Pack Model Number (Lot Numbers): 00643169505322, HY2Q32R9 (223366543, 224282023); 00643169572263, HY8L55R5 (222887140, 223145744, 223145745, 223283258, 223323300, 223685612, 223685613, 223685614, 223860888, 223860889, 224043160, 224327270, 224327271, 224454137, 224623800, 224623801, 224659584, 224838251, 224838252, 224838253, 225126458); 00643169618312, HY7S51R10 (223235000, 224155208, 224454025, 224794488, 224861211); 00643169661295, HY8M65R2 (224539804); 00643169713406, HY7V67R9 (223247291, 224112023, 224752769); 00643169724310, HY8S40R2 (222974852, 223196617, 223196618, 223810224, 223810366, 224282014, 224497799, 224497800, 225047871, 225047872); 00643169771260, M530636A (223439641, 223775523, 224138283, 224695541, 225162264, 225415719); 00643169792180, M274404N (223260993, 224168527, 224567881, 224865204, 225161917); 00643169930162, HY8B05R7 (222774169, 222974885, 222974886, 223283250, 223454 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1028-2023%22
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