Device product
HEMASHIELD Knitted Double Velour Cardiovascular Fabric
Z-1172-2018
Product summary
- Event
- Event 79536
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-1172-2018
Official wording
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).
Code information: UDI code: 00384401017899 Catalog number: M002000195140 Lot number: 16M21 Serial number: 1092238229
Distribution pattern: FL
Derived failure modes
-
Labeling or packaging
mislabeling