Reported May 13, 2020 · Terminated
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175828P0 - 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 CodeM00202175828P0 -
- Product Usagefor use in the replacement or repair of arteries affected with aneurysmal or occlusive disease
- Lot codes and dates
- Serial Numbers
207 of 207 codes
106901691510690167781069024392106902363310690209451069017069106988735910701752111070689212107069193810706922291073307657107327408310742397341074508943107672696310767241951076691012108051552710805025741080516052108052111510805178071080517202108051110410824962801107410936110740119611074120061108349382110838484911095272361109536351110958295911095458371109638521110971299311120193011112016613111201696411120167301112017860111201748911120183851112051221111203028311134571181113461382111341257411134465621113429579111582646111158641281115914431111591454811158271231115899734111589770811158253311115890109
- 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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