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Maquet Cardiovascular, LLC recalls Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
Recalled December 29, 2021 · FDA recall Z-0403-2022 · Maquet Cardiovascular
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. · FDA Class II
Units
2
Sold at
US Nationwide distribution in the states of IL and NC.
Description
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.
Product
Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
Manufacturer(s)
Maquet Cardiovascular, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →