Cook Inc.: Medical Device Recall in 2018 - (Recall #: Z-0958-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Fixed Core Wire Guide

Product Classification:

Class II

Date Initiated: October 13, 2017

Date Posted: March 21, 2018

Recall Number: Z-0958-2018

Event ID: 79195

Reason for Recall:

Label does not state that the product is heparin-coated.

Status: Terminated

Product Quantity: 601,778

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

Voluntary or Mandated:

Voluntary: Firm initiated