Device product
Bentson Cerebral Wire Guide
Z-0951-2018
Product summary
- Firm
- Cook Inc.
- Event
- Event 79195
- Status
- Terminated
- Classification
- Class II
- Quantity
- 45
- Official record key
device-enforcement:Z-0951-2018
Official wording
Reason: Label does not state that the product is heparin-coated.
Code information: Catalog # THSFB-35-145-BH Affected lots to include: F3813488 - F4859795 NS5327890 - NS6060291
Distribution pattern: Nationally
Derived failure modes
-
Labeling or packaging
Label does not state