Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER NUMBER (GPN): G56172. 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 75 units of the Roadrunner UniGlide Hydrophilic Wire Guide (Reference Part Number HPWA-35-80, Order Number G56172), a device used for vascular catheter positioning and exchange in diagnostic and interventional procedures. The product failed to meet acceptance criteria for packaging testing, specifically 3-year age acceleration testing, which means the sterility of the device may be compromised. The affected lot number is 14156569.
The recalled devices were distributed nationwide and in multiple foreign countries including Canada, Australia, the United Kingdom, Japan, Mexico, and others. The record does not specify a remedy 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: 75 units Lot/code info: UDI-DI: (01)00827002561724- Lot Numbers: 14156569
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.