Reported Nov 27, 2024 · Ongoing
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
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?
- Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
- Lot codes and dates
- Model Number C-OM-9000Z
- UDI-DI Number00607567900004
- Batch Numbers
30002704773000274130300027933330003250283000349295300035630530003685683000288446300031484130003181973000340989300031517930002846603000279342300032502530003409643000274640300028005930002805633000325362300028469530003148383000349055300035606330002989823000317739300037671130002798393000399170300036285330003371543000321412300029981430002884453000269996
- Amount recalled
- 10,778 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.
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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