Device product
ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part number 72023-02, Model Number VPR-GW-17. Five (5) guide wire pouches in one (1) guide wire box. For use with CSI Peripheral Orbital Atherectomy Devices (OAD), including Stealth 360 and Diamondback 360. Cardiovascular.
Z-2051-2016
Product summary
- Event
- Event 74445
- Status
- Terminated
- Classification
- Class II
- Quantity
- 190 units (38 - 5 pack shelf cartons)
- Official record key
device-enforcement:Z-2051-2016
Official wording
Reason: The pouch label was missing the use by date (UBD) of 2018-04.
Code information: Lot #160877, UDI Number: (01)10852528005084(17)180430(10)160877.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Labeling or packaging
label was missing