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

Recall Z-0535-2018 — Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.

U.S. FDA — Device Enforcement · United States · 2018-01-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0535-2018
Date of alert: 2018-01-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medtronic Perfusion Systems
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 20885074191038

Reported risk: Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve.

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-0535-2018 — Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.

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