Reported Oct 5, 2022 · Ongoing
Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN: PMG-18SP-60-COPE-NT-ST G09395…
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 |
|---|---|
G09395 | Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN: PMG-18SP-60-COPE-NT-ST |
G08687 | PMG-18SP-100-COPE-NT |
G08427 | PMG-18SP-60-COPE-NT |
- Lot codes and dates
- PMG-18SP-60-COPE-NT-ST G09395 UDI-DI00827002093959 Lot/Expiration Date 14809498 23-06-2027 14809499 23-06-2027 14811841 24-06-2027
- PMG-18SP-100-COPE-NT G08687 UDI-DI00827002086876 Lot/Expiration Date 14811839 24-06-2027 14839563 13-07-2027
- PMG-18SP-60-COPE-NT G08427 UDI-DI00827002084278 Lot/Expiration Date
1481675028-06-20271481675328-06-20271481675428-06-20271481675528-06-20271481675728-06-20271482175530-06-20271482175630-06-20271482175830-06-20271483133207-07-20271483133307-07-20271483133507-07-20271483133607-07-2027NS1481372527-06-2027NS1481675128-06-2027NS1482176030-06-2027NS1482806905-07-20271480949823-06-20271480949923-06-20271481184124-06-2027
- Amount recalled
- 1,501 US; 380 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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