FDA recall Z-0403-2022

Product

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.

Distribution

US Nationwide distribution in the states of IL and NC.

Key facts

Status

Terminated

Initiation date

2021-12-01

Report date

2021-12-29

Termination date

2024-02-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0403-2022