Reported Oct 5, 2022 · Ongoing
Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534
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?
- Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534
- Lot codes and dates
- RPC-35-145 G06979 UDI-DI00827002069794
- Lots/Expiration Date
1477416807-06-20251481002123-06-20251481349127-06-20251481622828-06-20251483504611-07-20251483504911-07-20251484550618-07-2025NS1481348927-06-2025NS14813489X27-06-2025
- RPC-35-80 G09534 UDI-DI00827002095342
- Lots/Expiration Date14823405 01-07-2025 14823407 01-07-2025 14823408 01-07-2025
- Amount recalled
- 363 US; 244 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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