medical Class II Updated 2020-05-13

Maquet Cardiovascular, LLC recalls HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Bra

Recalled Product

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.


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: 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
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