FDA Device recall Z-1172-2018
HEMASHIELD Knitted Double Velour Cardiovascular Fabric
- FDA Device
- Class II
- terminated
- Published 2018-04-04
On 2018-04-04 the FDA classified a Class II recall of HEMASHIELD Knitted Double Velour Cardiovascular Fabric by Getinge Us Sales, citing 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 insi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1172-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-03 |
| Published | 2018-04-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Getinge Us Sales |
| Distribution | FL |
Product
HEMASHIELD Knitted Double Velour Cardiovascular Fabric
Reason
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).
Identifiers
| code_info | UDI code: 00384401017899 Catalog number: M002000195140 Lot number: 16M21 Serial number: 1092238229 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1172-2018%22
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