Reported Oct 5, 2022 · Ongoing
Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-80-3 G00476
Cook Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cook Incorporated · 750 N Daniels Way · Bloomington, IN · 47404-9120
Is this the product you have?
- Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-80-3 G00476
- Lot codes and dates
- THSCF-25-180-3 G02165 UDI-DI00827002021655
- Lots/Expiration Dates14797761 16-06-2027 14813704 27-06-2027
- TSCF-25-80-3 G00476 UDI-DI00827002004764
- Lots/Expiration DatesNS14797766 16-06-2027 NS14807600 22-06-2027 NS14821727 30-06-2027
- Amount recalled
- 58 US; 5 OUS
This recall covers 24 products
The agency filed one notice per product. You are reading one of them; the other 23 are below.
11 more are in the archive.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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