CLASS II ONGOING Device recall · Reported 5 Oct 2022 · FDA Enforcement Report
Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference recalled
Cook Incorporated is recalling Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference, distributed nationwide in the US. The recall was initiated on 16 Aug 2022 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-1847-2022
- FDA event ID
- 90793
- Recalling firm
- Cook Incorporated, Bloomington, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Aug 2022
- FDA classified
- 28 Sep 2022
- Reported
- 5 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 16 Aug 2022 | Recall initiated by company | |
| 28 Sep 2022 | Classified by FDA | +43 days |
| 5 Oct 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-145 G01677
Where it was distributed
Domestic distribution nationwide. Foreign distribution worldwide.
Questions about this recall
Is Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference recalled?
Yes. Cook Incorporated recalled Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference on 16 Aug 2022. The recall is Class II and its status is Ongoing. Recall number Z-1847-2022.
Why was it recalled?
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Which lots are affected?
TMT-35-145 G01677 UDI-DI: 00827002016774 Lot/Expiration Date: 14808818 22-06-2027
Where was it sold?
Domestic distribution nationwide. Foreign distribution worldwide.
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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