Reported Nov 27, 2024 · Ongoing
Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
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 Vacuum Stabilizer System. Model Number C-OM-10000Z
- Lot codes and dates
- Model Number C-OM-10000Z
- UDI-DI Number00607567100008
- Batch Numbers
105 of 105 codes
300027722130002865493000315868300031751730003225383000339447300036302830002707133000275435300027577130002808683000284390300030314930003216423000342528300033607030003221793000337396300027318230002821813000337880300035353530003641723000357109300027610930003381073000354445300035505030003528993000324785300036089430003707203000323627300034633030003567403000278665300034401230003667293000361801300040092830003637753000311956300034355330003675593000377818300034143030003673453000336377300031620830003814493000380956300040375630003214143000361499300040780930003980303000387678300032007730002770723000283754
- Amount recalled
- 33,823 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.
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.
Free recall alerts
Get alerted about new packaged foods recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.