Device product
Fixed Core Wire Guide
Z-0958-2018
Product summary
- Firm
- Cook Inc.
- Event
- Event 79195
- Status
- Terminated
- Classification
- Class II
- Quantity
- 601,778
- Official record key
device-enforcement:Z-0958-2018
Official wording
Reason: Label does not state that the product is heparin-coated.
Code information: Catalog # C-SCF-/-BH C-SF-/-BH SF-/-BH THSCF-/-BH THSF-/-BH TSCF-/-BH TSCFR-/-BH TSF-/-BH Affected lot codes range from: 3730001 - 6164916 F3729969 - F4922979 NS4928020 - NS6203182 Affected lot codes range from: 3733552 - 6175191 F3729974 - F4923948 NS4927345 - NS6177894 F3753452 - F4925547 NS5008794 - NS6171324 F3922830 - F4218188 NS5470403 - NS6020850 F4087814 - F4741344 NS4929840 - NS5104065 F4119548 - F4920483 NS5171771 - NS6144080 3730875 - 6180567 F3730082 - F4924418 NS4928022 - NS6177724 NS5185993 3730101 - 6181269 F3734860 - F4923958 NS4927349 - NS6203187
Distribution pattern: Nationally
Derived failure modes
-
Labeling or packaging
Label does not state