FDAFDA · Food and drugs·Recall number Z-1875-2020
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code: M00202175834P0 - 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: 1069033761 1069030839 1071600069 1071620833 1071615770 1071620950 1074557517 1074562931 1077531880 1109551893 1109625685 1113411073 1115932310 1160529586 1160492194 1160491552 1160727457 1160529957 1182769563 1182780936 1182789351 1182792017 1183481796 1069032514 1115876907 1115936362 1137588685
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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