Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937. 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 496 units of the Roadrunner PC Hydrophilic Wire Guide (model RFPC-35-180, GPN G07937), a device used for vascular catheter positioning and exchange in diagnostic and interventional procedures. The recall affects specific lot numbers (14145420, 14145424, 14156909, 14156912, 14156916, 14164348, and 14173577) distributed nationwide and internationally across multiple countries. The product 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 was issued because the failed packaging testing raises concerns that the device's sterile barrier may have been breached, potentially exposing users to contamination. The affected product was distributed across North America, Europe, South America, Asia, and other regions. The source document does not specify what actions affected consumers or healthcare providers should take regarding this recall.
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: 496 units Lot/code info: UDI-DI: (01)00827002079373- Lot Numbers: 14145420, 14145424, 14156909, 14156912, 14156916, 14164348, 14173577
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.