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

Recall Z-0160-2013 — QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000 Product Usage: The QUADROX oxygenators are intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow r

U.S. FDA — Device Enforcement · United States · 2012-06-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0160-2013
Date of alert: 2012-06-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Maquet Cardiovascular Us Sales, Llc
Product category: device
Product type: Devices

Reported risk: It has come to firm's attention that, in some rare cases, the blood outlet connector on some models of MAQUET Oxygenators may detach from the oxygenator. This event has occurred in about 0.01% (1:10,000) of units shipped.

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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