Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151. 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 (Reference Part Number HPWS-35-80, Order Number G56151), a device used for vascular catheter positioning and exchange in diagnostic and interventional procedures. The recall affects 15 units with lot number 14156572 that were distributed nationwide and internationally to countries including Canada, Australia, Japan, Mexico, and others.
The product is being recalled because it did not meet acceptance criteria for packaging testing, specifically 3-year age acceleration testing. As a result, the sterility of the device may be compromised. The source document 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: 15 units Lot/code info: UDI-DI: (01)00827002561519- Lot Numbers: 14156572
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.