Device product
Disposable Reuter Tip Deflecting Wire Guide
Z-0955-2018
Product summary
- Firm
- Cook Inc.
- Event
- Event 79195
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18,398
- Official record key
device-enforcement:Z-0955-2018
Official wording
Reason: Label does not state that the product is heparin-coated.
Code information: Catalog # DTDW-/-BW Affected lots to include: 3730008 - 6164931 F4374635 - F4791430 NS5034700 - NS5562947
Distribution pattern: Nationally
Derived failure modes
-
Labeling or packaging
Label does not state