medical Class II Updated 2020-05-13

Maquet Cardiovascular, LLC recalls HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Bra

Recalled Product

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.


Hazard / Issue

Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: 1131533749 1131512226 1137644576 1143574839 1143575130 1148758791 1148780115 1148765763 1148821303 1148781616 1148788961 1148782980 1162315753 1165124869 1192273190 1135377032 1136549649 1137644693 1148748780 1162373559
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