Cook recalls Roadrunner UniGlide Hydrophilic Wire Guide (RPN HPWAS-35-150) due to potential sterility compromise from inadequate packaging testing. Affected units include specific lot numbers for vascular catheter procedures.
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.
Cook is recalling its Roadrunner UniGlide Hydrophilic Wire Guide devices because the packaging may not have passed long-term testing, risking contamination. This could lead to infections if the device is used in medical procedures without proper sterility.
The device's packaging failed 3-year age acceleration testing, which means the sterility could be compromised over time. This increases the risk of contamination during medical procedures, potentially causing infections.
Healthcare professionals using the device for vascular catheter procedures are most at risk. Patients receiving these devices during medical treatments could be affected if the sterility is compromised.
Check for reference part number HPWAS-35-150 and order number G56176. Affected units include specific lot numbers listed in the recall notice.
Look for lot numbers on the device packaging: 14112845, NS14062106, NS14080814, NS14089120, NS14118843, NS14139358, NS14142006, NS14144747, NS14148490, NS14149799, NS14153797, NS14172915.
The packaging failed 3-year age acceleration testing, which could compromise the device's sterility over time.
If the sterility is compromised, it could lead to infections during medical procedures.
Check for reference part number HPWAS-35-150 and order number G56176 with the listed lot numbers.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1715-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1715-2022 from Cook. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
