Reported May 13, 2020 · Terminated
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175832P0 - Product Usage: for use…
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?
- HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch
- Product CodeM00202175832P0 -
- Product Usagefor use in the replacement or repair of arteries affected with aneurysmal or occlusive disease
- Lot codes and dates
- Serial Numbers
107159222710766523321076651924107753026210775324251077534451111587413911178093711117812408111779632711177945351117789960111780902011178159351117814805112395117511239880851124019782112404032711240211811124006732112958995911296349431129655139113659590611376137641139537978114368413511467210321146770074114675383311467145481146754846114676742811605280851160522358116054058811604899191185176976118574244511873003371187355243118733658510722262831115901732111778617911240020551123995779113760094811395359521143697322114672380011467252211160566357
- Serial Numbers
- Amount recalled
- N/A
This recall covers 24 products
The agency filed one notice per product. You are reading one of them; the other 23 are below.
11 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
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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