Reported Oct 5, 2022 · Ongoing
Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356 THSF-38-145-COONS…
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?
4 of 4 products
| Model / number | Product as published |
|---|---|
G02356 | Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS |
G02324 | THSF-38-145-COONS |
G02621 | THSF-35-180-COONS |
G12268 | THSF-35-80-COONS |
- Lot codes and dates
- THSF-35-145-COONS G02356 UDI-DI 00827002023567 Lot/Expiration DateUDI-DI 00827002023246 Lot/Expiration Date 14793057 14-06-2027 THSF-35-180-COONS G02621 UDI-DI 00827002026216 Lot/Expiration Date 14797773 16-06-2027 THSF-35-80-COONS G12268
1475781827-05-20271479505915-06-20271479778116-06-20271480236320-06-2027THSF-38-145-COONSG02324
- THSF-35-145-COONS G02356 UDI-DI 00827002023567 Lot/Expiration Date
- Amount recalled
- 1,236 US
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.
Want the full recall guide?
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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