Device product
Fixed Core Bentson
Z-0957-2018
Product summary
- Firm
- Cook Inc.
- Event
- Event 79195
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,210
- Official record key
device-enforcement:Z-0957-2018
Official wording
Reason: Label does not state that the product is heparin-coated.
Code information: Catalog # TSCFB-/-BH Affected lots range from: F3734676 - F4911986 NS4938980 - NS6144078
Distribution pattern: Nationally
Derived failure modes
-
Labeling or packaging
Label does not state