Device product
Coons Interventional Wire Guide
Z-0954-2018
Product summary
- Firm
- Cook Inc.
- Event
- Event 79195
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,369
- Official record key
device-enforcement:Z-0954-2018
Official wording
Reason: Label does not state that the product is heparin-coated.
Code information: Catalog # THSF-/-COONS-BH Affected lot codes range from: 3730001 - 6164916 F3729969 - F4922979 NS4928020 - NS6203182
Distribution pattern: Nationally
Derived failure modes
-
Labeling or packaging
Label does not state