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.
Check against the official notice below — it lists the full affected range.
Cook Incorporated is recalling the Roadrunner UniGlide Hydrophilic Wire Guide (Part Number HPWAS-35-150, Order Number G56176), a device used for vascular catheter positioning and exchange in diagnostic and interventional procedures. The recall affects 865 units 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 affected lot numbers are: 14112845, NS14062106, NS14080814, NS14089120, NS14118843, NS14139358, NS14142006, NS14144747, NS14148490, NS14149799, NS14153797, and NS14172915. The recall record does not specify a remedy or recommended action for 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: 865 units Lot/code info: UDI-DI: (01)00827002561762- Lot Numbers: 14112845, NS14062106, NS14080814, NS14089120, NS14118843, NS14139358, NS14142006, NS14144747, NS14148490, NS14149799, NS14153797, NS14172915
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.