Z-1710-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 21, 2022
- Initiation Date
- July 19, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 585 units
Product Description
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
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 Pattern
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
Code Information
UDI-DI: (01)00827002561496- Lot Numbers: 14070921, 14108915, 14108916, 14129152, 14141997, 14170230