Device product
TFE Coated Curved Newton LLT
Z-0963-2018
Product summary
- Firm
- Cook Inc.
- Event
- Event 79195
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,364
- Official record key
device-enforcement:Z-0963-2018
Official wording
Reason: Label does not state that the product is heparin-coated.
Code information: Catalog # TSCFNB-35-180-SPENCERMOD- BH Affected lots to include: 3741882 - 6142463 F3884311 - F4903643 NS5044201 - NS5963180
Distribution pattern: Nationally
Derived failure modes
-
Labeling or packaging
Label does not state