Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER NUMBER (GPN) G07516. 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 has recalled 1,450 units of the Roadrunner PC Hydrophilic Wire Guide (part number RLPC-35-180, order number G07516), a device used for vascular catheter positioning and exchange in diagnostic and intervention procedures. The recall affects specific lot numbers: 14103953, 14103956, 14143728, 14145412, 14145419, 14153927, 14156907, 14156908, 14156914, and 14160996. The product has been distributed nationwide and internationally across multiple countries.
The device is being recalled because it did not meet acceptance criteria for packaging testing, including 3-year age acceleration testing, which means the sterility of the device may be compromised. The recall notice does not specify a remedy or recommended 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: 1450 units Lot/code info: UDI-DI: (01)00827002075160- Lot Numbers: 14103953, 14103956, 14143728, 14145412, 14145419, 14153927, 14156907, 14156908, 14156914, 14160996
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.