Device product
Double Flexible Tipped Wire Guide
Z-0956-2018
Product summary
- Firm
- Cook Inc.
- Event
- Event 79195
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,367
- Official record key
device-enforcement:Z-0956-2018
Official wording
Reason: Label does not state that the product is heparin-coated.
Code information: Catalog # DTDW-/-BW Affected lots include: F3749839 - F4849938 NS5085893 - NS5827127 F4628078 - F4856722 3763189 - 6106860 F3739663 - F4916737 NS4980257 - NS6098990
Distribution pattern: Nationally
Derived failure modes
-
Labeling or packaging
Label does not state