Reported Sep 21, 2022 · Ongoing
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-150 ORDER NUMBER (GPN): G56173. For…
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 UniGlide Hydrophilic
- Wire Guide REFERENCE PART NUMBER (RPN)HPWA-35-150
- ORDER NUMBER (GPN)G56173. For vascular catheter positioning and exchange in diagnostic and interventional procedures
- Lot codes and dates
- UDI-DI(01)00827002561731-
- Lot Numbers
61 of 61 codes
14070910140709131407091414070915140709161407091714080810141048981410489914104902141066281410662914120473141204741412047514122089141220911412209314122095141223221412915514129156141291571412915814129161141291621412916314131012141310131413101414134680141346811413468314134684141393561414200114142004141420051414200714147337141473381414733914148371141605311416053314160534NS14095649NS14122100NS14122327NS14129168NS14131010NS14131011NS14131015NS14133505NS14142008NS14147334NS14147335NS14147336NS14147336XNS14153793
- Amount recalled
- 5400 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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