Reported Oct 5, 2022 · Ongoing
Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183…
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?
3 of 3 products
| Model / number | Product as published |
|---|---|
G05183 | Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE |
G05822 | PMG-18SP-100-COPE |
G10077 | PMG-18SP-125-COPE |
- Lot codes and dates
- PMG-18SP-60-COPE G05183 UDI-DI00827002051836 Lot/Expiration Date
1479501215-06-20271480163620-06-20271480426421-06-20271480426521-06-20271480698422-06-20271480698522-06-20271481584127-06-20271481584227-06-20271481585227-06-20271481585327-06-20271481585427-06-20271481908029-06-20271481908129-06-20271483120507-07-20271483120607-07-20271484123614-07-2027
- PMG-18SP-100-COPE G05822 UDI-DI00827002058224 Lots/Expiration Dates 14797819 16-06-2027
- PMG-18SP-125-COPE G10077 UDI-DI00827002100770 Lots/Expiration Dates 14809295 23-06-2027 14809296 23-06-2027
- PMG-18SP-60-COPE G05183 UDI-DI00827002051836 Lot/Expiration Date
- Amount recalled
- 2,748 US; 302 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.
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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