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: M00202175924P0 - 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: 1130028529 1138737382 1151582817 1151580283 1153694149 1158765278 1165139009 1165161757 1165201073 1165174827 1165129349 1165209939 1165131353 1165124986 1180826106 1138872368 1153712022 1157288202 1158765044 1165159382
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