Medtronic Perfusion Systems Recall: Custom Pack Perfusion Tubing Packs containing Affinity
Medtronic Perfusion Systems Recall: Custom Pack Perfusion Tubing Packs containing Affinity is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Medtronic Perfusion Systems; Product: Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and
| Recalling firm | Medtronic Perfusion Systems |
|---|---|
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | Worldwide distribution. US Nationwide, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Belgium, Plurinational State of Bolivia, Bosnia And Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denm |
| Recall initiated | 20221212 |
| Recall number | Z-1028-2023 |
| Category | device |
| State | MN |
| Country | United States |
$29/mo
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