Device product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBER (GPN): G56176. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Z-1715-2022
Product summary
- Event
- Event 90710
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 865 units
- Official record key
device-enforcement:Z-1715-2022
Official wording
Reason: 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.
Code information: UDI-DI: (01)00827002561762- Lot Numbers: 14112845, NS14062106, NS14080814, NS14089120, NS14118843, NS14139358, NS14142006, NS14144747, NS14148490, NS14149799, NS14153797, NS14172915
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
Derived failure modes
-
Unknown
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.