Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149. 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 HPW-35-150, order number G56149) used for vascular catheter positioning and exchange in diagnostic and interventional procedures. The recall affects 585 units distributed nationwide and internationally across multiple countries. The product is being recalled because it failed packaging testing requirements, including 3-year age acceleration testing, which means the sterility of the device may be compromised.
The affected lots are: 14070921, 14108915, 14108916, 14129152, 14141997, and 14170230 (identified by UDI-DI 00827002561496). The source document does not specify a remedy or instructions for what affected consumers should do.
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: 585 units Lot/code info: UDI-DI: (01)00827002561496- Lot Numbers: 14070921, 14108915, 14108916, 14129152, 14141997, 14170230
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.