Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1023-2023 — Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.

U.S. FDA — Device Enforcement · United States · 2022-12-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1023-2023
Date of alert: 2022-12-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medtronic Perfusion Systems
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 8111483548

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1023-2023 — Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.

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