Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-80 ORDER NUMBER (GPN): G56162. 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 35 units of the Roadrunner UniGlide Hydrophilic Wire Guide (model HPWA-18-80, order number G56162), a device used for vascular catheter positioning and exchange in diagnostic and interventional procedures. The recall affects lot numbers 14070920 and 14174878, which were distributed nationwide and internationally to countries including Canada, Australia, Japan, and numerous others.
The product failed to meet packaging testing acceptance criteria, specifically 3-year age acceleration testing, which means the sterility of the device may be compromised. According to the recall record provided, no remedy is specified 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: 35 units Lot/code info: UDI-DI: (01)00827002561625- Lot Numbers: 14070920, 14174878
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.