HEMASHIELD Knitted Double Velour Cardiovascular Fabric — Class II medical device recall Z-1172-2018
Terminated recall by GETINGE US SALES LLC, reported 2018-04-04, distributed in FL. A probable mislabeling of the product: a different-sized product is referenced on the product packaging label
| Recall number | Z-1172-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GETINGE US SALES LLC, Wayne, NJ, United States |
| Recall initiated | 2018-01-03 |
| Classified | 2018-03-23 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2018-07-03 |
| Distributed | FL |
| Quantity | 1 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00384401017899 |
| Lot numbers | 16M21 |
| Serial numbers | 1092238229 |
| Model numbers | M002000195140 |
Product
HEMASHIELD Knitted Double Velour Cardiovascular Fabric
Reason for recall
A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual product inside the box is 2.5 cm (width) x 15 cm (length).
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-1172-2018. 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.