Reported Sep 21, 2022 · Ongoing
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vascular…
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 Hydrophilic
- Wire Guide REFERENCE PART NUMBER (RPN)RPC-35-180
- ORDER NUMBER (GPN)G07518. For vascular catheter positioning and exchange in diagnostic and interventional procedures
- Lot codes and dates
- UDI-DI(01)00827002075184
- Lot Numbers
140633611408708914087092141170331412092614120928141512161415121814153159141586141415969514159696
- Amount recalled
- 1997 units
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
Why it was recalled
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device 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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