Hemashield Gold Knitted Bifurcated — Class II medical device recall Z-0403-2022
Terminated recall by Maquet Cardiovascular, LLC, reported 2021-12-29, distributed nationwide. There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graf
| Recall number | Z-0403-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular, LLC, Wayne, NJ, United States |
| Recall initiated | 2021-12-01 |
| Classified | 2021-12-20 |
| Reported by FDA | 2021-12-29 |
| Terminated | 2024-02-28 |
| Distributed | Nationwide (US) |
| Quantity | 2 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00384401017752 |
| Lot numbers | 20C04 |
| Serial numbers | 1259882880, 1260004700 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0403-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.