FDAFDA · Food and drugs·Recall number Z-1882-2020
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175930P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Published May 13, 2020 · Recall initiated: April 7, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Maquet Cardiovascular, LLC
- Distributor
- Worldwide distribution - US Nationwide distribution and the countries of Dubai, Argentina, Austria, Belgium, Brazil, Japan, Canada, China, Germany, Spain, Finland, France, UK, Hongkong, Italy, Korea, Netherlands, Poland, Serbia, Sweden.
- Lot
- Serial Numbers: 1131533749 1131512226 1137644576 1143574839 1143575130 1148758791 1148780115 1148765763 1148821303 1148781616 1148788961 1148782980 1162315753 1165124869 1192273190 1135377032 1136549649 1137644693 1148748780 1162373559
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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