Device product
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Z-1709-2022
Product summary
- Event
- Event 90710
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1997 units
- Official record key
device-enforcement:Z-1709-2022
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)00827002075184 Lot Numbers: 14063361, 14087089, 14087092, 14117033, 14120926, 14120928, 14151216, 14151218, 14153159, 14158614, 14159695, 14159696
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.