PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: December 29, 2021 Initiated: December 1, 2021 #Z-0403-2022

Product Description

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

Reason for Recall

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.

Details

Units Affected
2
Distribution
US Nationwide distribution in the states of IL and NC.
Location
Wayne, NJ

Frequently Asked Questions

What product was recalled?
Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890. Recalled by Maquet Cardiovascular, LLC. Units affected: 2.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 29, 2021. Severity: Moderate. Recall number: Z-0403-2022.