Reported Apr 20, 2016 · Terminated
Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator
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?
- Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator
- Lot codes and dates
BEQ-RF32BEQ-RF-32-USABO-RF-32BO-RF-32 USARF-32RF-32 USARF-32u
- Amount recalled
- 72,000 units in total
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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