CLASS II Device recall · Reported 21 Mar 2018 · FDA Enforcement Report
Fixed Core Wire Guide recalled by Cook
Cook is recalling Fixed Core Wire Guide, distributed nationwide in the US. The recall was initiated on 13 Oct 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0958-2018
- FDA event ID
- 79195
- Recalling firm
- Cook, Bloomington, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Oct 2017
- FDA classified
- 9 Mar 2018
- Reported
- 21 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 13 Oct 2017 | Recall initiated by company | |
| 9 Mar 2018 | Classified by FDA | +147 days |
| 21 Mar 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Label does not state that the product is heparin-coated.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Fixed Core Wire Guide
Where it was distributed
Nationally
Questions about this recall
Is Fixed Core Wire Guide recalled?
Yes. Cook recalled Fixed Core Wire Guide on 13 Oct 2017. The recall is Class II and its status is Terminated. Recall number Z-0958-2018.
Why was it recalled?
Label does not state that the product is heparin-coated.
Which lots are affected?
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
Where was it sold?
Nationally
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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