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

Recall Z-1198-2021 — Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoa

U.S. FDA — Device Enforcement · United States · 2021-02-04 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1198-2021
Date of alert: 2021-02-04
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Medtronic Perfusion Systems
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00763000240288

Reported risk: Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.

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

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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.

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