Device product
Reuter Tip Deflecting Wire Guide
Z-0961-2018
Product summary
- Firm
- Cook Inc.
- Event
- Event 79195
- Status
- Terminated
- Classification
- Class II
- Quantity
- 55
- Official record key
device-enforcement:Z-0961-2018
Official wording
Reason: Label does not state that the product is heparin-coated.
Code information: Catalog # TDW-/-SGH-BH Affected lots to include: F4423853 - F4898351 NS5072022 - NS6166764
Distribution pattern: Nationally
Derived failure modes
-
Labeling or packaging
Label does not state