FDA Device recall Z-0403-2022
Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm
- FDA Device
- Class II
- terminated
- Published 2021-12-29
On 2021-12-29 the FDA classified a Class II recall of Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm by Maquet Cardiovascular, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0403-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-12-01 |
| Published | 2021-12-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Maquet Cardiovascular |
| Distribution | US |
Product
Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
Reason
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.
Identifiers
| code_info | Lot number: 20C04; Serial Numbers: 1260004700 and 1259882880; UDI Code: (01)00384401017752(11)200304(17)250228(21)126…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0403-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.