Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-80 ORDER NUMBER (GPN): G56175. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Check against the official notice below — it lists the full affected range.
Cook Incorporated is recalling 189 units of the Roadrunner UniGlide Hydrophilic Wire Guide (Part Number HPWAS-35-80, Order Number G56175), a device used for vascular catheter positioning and exchange in diagnostic and interventional procedures. The recall affects four specific lot numbers: 14174876, 14174880, NS14104906, NS14173970, and NS14173971, which were distributed nationwide and internationally across multiple countries.
The product is being recalled because it did not meet acceptance criteria for packaging testing, including 3-year age acceleration testing, which means the sterility of the device may be compromised. The recall notice does not specify a remedy or instructions for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: 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 Quantity: 189 units Lot/code info: UDI-DI: (01)00827002561755- Lot Numbers: 14174876, 14174880, NS14104906, NS14173970, NS14173971
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.