Reported Nov 27, 2024 · Ongoing
Acrobat-i Positioner. Model Number C-XP-5000Z
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-i Positioner. Model Number C-XP-5000Z
- Lot codes and dates
- Model Number C-XP-5000Z
- UDI-DI Number00607567500006
- Batch Numbers
300027245230002892703000293675300034040130003822893000282355300028720530002903683000306921300030823830003074583000318694300028274130002903503000306394300033412830003553183000362345300027826630003434673000353846300034642130003602923000364706300031754630002724613000343116300036017530003605693000355540300038014130003788103000334322300036304930003117313000306920300036513930002738553000300092300027633930003473513000347358300035224930003971513000368288300029395830002883563000286557300040280930003925903000340972
- Amount recalled
- 14,338 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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