Device product
Amplatz Extra Stiff Whisker Wire Guide
Z-0947-2018
Product summary
- Firm
- Cook Inc.
- Event
- Event 79195
- Status
- Terminated
- Classification
- Class II
- Quantity
- 648
- Official record key
device-enforcement:Z-0947-2018
Official wording
Reason: Label does not state that the product is heparin-coated.
Code information: Catalog # THSCF-35-260-3-AESW-BH Affected lot codes range from: 3733552 - 6175191 F3729974 - F4923948 NS4927345 - NS6177894
Distribution pattern: Nationally
Derived failure modes
-
Labeling or packaging
Label does not state