FDADecember 1, 2021device

Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graft, SN 1259735369, 24 mm x 12 mm, REF Number M00202166241P0 is likely packaged inside of the carton instead of a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1260004700; 18 mm x 9 mm; REF Number M002020851890 or a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1259882880; 18 mm x 9 mm; Ref Number M002020851890.

What to do

FDA enforcement status: Terminated

Brands named

maquet cardiovascularmaquet

UPCs

00384401017752

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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