Reported Jun 7, 2023 · Ongoing
BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859
Maquet Medical Systems USA
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 Medical Systems USA · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
- BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859
- Lot codes and dates
- UDI-DI04058863019024 All lots
- Amount recalled
- 15,880 (US)
This recall covers 18 products
The agency filed one notice per product. You are reading one of them; the other 17 are below.
5 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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