FDAFDA · Food and drugs·Recall number Z-1869-2020
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175822P0 - 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: 1070624412 1072306151 1072300424 1123884494 1131457231 1131669419 1133302679 1151507540 1151511687 1152707813 1152559041 1152750757 1070621236 1070629009 1074513986 1074512017 1123911970 1131472773 1131605144 1152580776 1153707701
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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