Device product
Newton Wire Guide
Z-0960-2018
Product summary
- Firm
- Cook Inc.
- Event
- Event 79195
- Status
- Terminated
- Classification
- Class II
- Quantity
- 41,113
- Official record key
device-enforcement:Z-0960-2018
Official wording
Reason: Label does not state that the product is heparin-coated.
Code information: Catalog #THSCFNB-/-BH TSCFNA-BH TSCFNB-/-BH TSFNA-/-BH TSFNB-/-BH Affected lots range from: 3733537 - 5803299 F3762971 - F4692445 NS5043714 - NS5900771 3766161 - 5925080 F3753484 - F4887253 NS4938982 - NS5932560 F4556472 - F4718761 NS6024246 3741877 - 5929842 F3749985 - F4903656 NS4928037 - NS5963186 3744567 - 6253002 F3763300 - F4900931 NS4928039 - NS59824 3741882 - 6142463 F3884311 - F4903643 NS5044201 - NS5963180
Distribution pattern: Nationally
Derived failure modes
-
Labeling or packaging
Label does not state