Z-0403-2022 Class II Terminated
FDA device recall Z-0403-2022 was initiated by Maquet Cardiovascular, LLC on December 1, 2021 and is designated Class II. 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 t… The recall status is terminated (terminated February 28, 2024). Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- December 29, 2021
- Initiation Date
- December 1, 2021
- Termination Date
- February 28, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
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.
Distribution Pattern
US Nationwide distribution in the states of IL and NC.
Code Information
Lot number: 20C04; Serial Numbers: 1260004700 and 1259882880; UDI Code: (01)00384401017752(11)200304(17)250228(21)1260004700GS(10)20C04 (01)00384401017752(11)200304(17)250228(21)1259882880GS(10)20C04