Reported Oct 2, 2013 · Terminated
QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD…
Maquet Cardiovascular US Sales, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Cardiovascular Us Sales, Llc · 45 Barbour Pond Drive · Wayne, NJ · 07470
Is this the product you have?
- QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
- Lot codes and dates
- QUADROX-iD Adult catalog number HMOD 70000, lot # 70081567 QUADROX-i Adult catalog number VKMO 70000, lot # 70082663 QUADROX-i Adult catalog number VKMO 71000, lot # 70083974
- Amount recalled
- 1,182 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
The manufacturer has conducted a review of the results of product testing performed during the last twelve months and has identified specific lots of product which may not meet specifications for bond strength on the inlet and/or outlet connector.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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