FDAFDA · Food and drugs·Recall number Z-1715-2022
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBER (GPN): G56176. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Published September 21, 2022 · Recall initiated: July 19, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cook Incorporated
- Distributor
- 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 SI TR UY ZA
- Lot
- UDI-DI: (01)00827002561762- Lot Numbers: 14112845, NS14062106, NS14080814, NS14089120, NS14118843, NS14139358, NS14142006, NS14144747, NS14148490, NS14149799, NS14153797, NS14172915
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.