medical Class II Updated 2020-05-13

Maquet Cardiovascular, LLC recalls HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Br

Recalled Product

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.


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: 1070624412 1072306151 1072300424 1123884494 1131457231 1131669419 1133302679 1151507540 1151511687 1152707813 1152559041 1152750757 1070621236 1070629009 1074513986 1074512017 1123911970 1131472773 1131605144 1152580776 1153707701
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