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.
This recall has been terminated (originally issued June 13, 2016).
- Company
- Cardiovascular Systems Inc
- Recall Initiated
- June 13, 2016
- Terminated
- August 16, 2016
- Recall Number
- Z-2051-2016
- Quantity
- 190 units (38 - 5 pack shelf cartons)
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
The pouch label was missing the use by date (UBD) of 2018-04.
Distribution
US Nationwide distribution.
Lot / Code Info
Lot #160877, UDI Number: (01)10852528005084(17)180430(10)160877.
Root Cause
Process control
Action Taken
Consignees were sent on 6/13/16 a Cardiovascular Systems, Inc. "Urgent Correction" letter date June 10, 2016. The letter described the problem and the affected product. Advised consignees to set affected product aside for their sales representative which will be applying the correct pouch label to the affected product. Requested consignees to fill and sign the Customer Acknowledgement Form that the sales representative will be presenting to them. For questions contact Quality at Cardiovascular Systems, Inc. 1-651-259-2068 1225 Old Highway 8 NW Saint Paul, MN 55112.