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

Recall Z-1636-2023 — BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item no. 701067905

U.S. FDA — Device Enforcement · United States · 2023-05-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1636-2023
Date of alert
2023-05-18
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Maquet Medical Systems USA
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04058863019079
Reported risk: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.
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.