Cook Incorporated 2022-09-21 Health serious FDA
Health · FDA · Recall #FDA-Z-1715-2022
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 … Recall
Issued September 21, 2022 · Cook Incorporated
In September 2022, Cook Incorporated recalled the Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 …, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 … right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Cook Incorporated to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Cook Incorporated
- Category
- Health
- Recall date
- September 21, 2022
- Units affected
- Not reported
- Sold at
- Nationwide Foreign: AR AT AU BE BG CA CA CH CL CN CZ DE DK ES FR GB GR GU HU IL IT JO JP KR KW MX MY NC NL PE PL PR PT PY RU SE
- Recall number
- FDA-Z-1715-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Cook Incorporated has 12 recalls in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.