Reported Jun 5, 2019 · Terminated
Maquet Getinge-BEQ-TOP 30901 CUSTOM CPB PACK Material:701063071
Maquet Cardiovascular, 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, LLC · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
- Maquet Getinge-BEQ-TOP 30901
- CUSTOM CPB PACK Material701063071
- Lot codes and dates
- Batch Numbers3000044877 3000045089 3000045951
- Amount recalled
- N/A
This recall covers 183 products
The agency filed one notice per product. You are reading one of them; the other 182 are below.
170 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
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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