Z-1713-2022 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
- 5400 units
Product Description
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-150 ORDER NUMBER (GPN): G56173. 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)00827002561731- Lot Numbers: 14070910, 14070913, 14070914, 14070915, 14070916, 14070917, 14080810, 14104898, 14104899, 14104902, 14106628, 14106629, 14120473, 14120474, 14120475, 14122089, 14122091, 14122093, 14122095, 14122322, 14129155, 14129156, 14129157, 14129158, 14129161, 14129162, 14129163, 14131012, 14131013, 14131014, 14134680, 14134681, 14134683, 14134684, 14139356, 14142001, 14142004, 14142005, 14142007, 14147337, 14147338, 14147339, 14148371, 14160531, 14160533, 14160534, NS14095649, NS14122100, NS14122327, NS14129168, NS14131010, NS14131011, NS14131015, NS14133505, NS14142008, NS14147334, NS14147335, NS14147336, NS14147336X, NS14153793, NS14176970