Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152. 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 30 units of Roadrunner UniGlide Hydrophilic Wire Guide (Reference Part Number HPWS-35-150, Order Number G56152), a device used for vascular catheter positioning and exchange in diagnostic and interventional procedures. The recall was initiated because the product failed packaging testing requirements, including 3-year age acceleration testing, which means the sterility of the device may be compromised.
The affected product has Lot Number 14118842 and was distributed nationwide and internationally to countries including Canada, Australia, Japan, Mexico, and others. The record does not specify what consumers or healthcare providers should do 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: 30 units Lot/code info: UDI-DI: (01)00827002561526- Lot Numbers: 14118842
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.