FDA Enforcement
Class II
Terminated
Fixed Core Wire Guide
Recall: Z-0958-2018
·
Reported March 21, 2018
Enforcement
- Recall Number
- Z-0958-2018
- Event ID
- 79195
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Cook Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 21, 2018
- Initiation Date
- October 13, 2017
- Classification Date
- March 9, 2018
- Termination Date
- October 23, 2019
- Address
- 750 N Daniels Way, Bloomington, IN, 47404-9120, United States
Description
Fixed Core Wire Guide
Reason
Label does not state that the product is heparin-coated.
Code Info
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
Nationally
Quantity
601,778