medical Class II Updated 2020-05-13

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

Recalled Product

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175832P0 - 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: 1071592227 1076652332 1076651924 1077530262 1077532425 1077534451 1115874139 1117809371 1117812408 1117796327 1117794535 1117789960 1117809020 1117815935 1117814805 1123951175 1123988085 1124019782 1124040327 1124021181 1124006732 1129589959 1129634943 1129655139 1136595906 1137613764 1139537978 1143684135 1146721032 1146770074 1146753833 1146714548 1146754846 1146767428 1160528085 1160522358 1160540588 1160489919 1185176976 1185742445 1187300337 1187355243 1187336585 1072226283 1115901732 1117786179 1124002055 1123995779 1137600948 1139535952 1143697322 1146723800 1146725221 1160566357

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