Device product
Left Atrial Catheter Set
Z-0965-2018
Product summary
- Firm
- Cook Inc.
- Event
- Event 79195
- Status
- Terminated
- Classification
- Class II
- Quantity
- 56
- Official record key
device-enforcement:Z-0965-2018
Official wording
Reason: Label does not state that the product is heparin-coated.
Code information: Catalog # C-ULAP-5.0-60-DTK-BH ALL LOTS
Distribution pattern: Nationally
Derived failure modes
-
Labeling or packaging
Label does not state