Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150 ORDER NUMBER (GPN):G56161. 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 85 units of the Roadrunner UniGlide Hydrophilic Wire Guide (model HPWA-18-150, order number G56161), a device used for vascular catheter positioning and exchange in diagnostic and interventional procedures. The recall affects two lot numbers: 14095646 and 14174879. The product was distributed nationwide and internationally to countries including Canada, Australia, Japan, Mexico, and others.
The recall was initiated because the product 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 recall notice does not specify a remedy or recommended course of action 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: 85 units Lot/code info: UDI-DI: (01)00827002561618- Lot Numbers: 14095646, 14174879
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.