FDA Enforcement
Class II
Terminated
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.
Recall: Z-2051-2016
·
Reported July 6, 2016
Enforcement
- Recall Number
- Z-2051-2016
- Event ID
- 74445
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Cardiovascular Systems Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 6, 2016
- Initiation Date
- June 13, 2016
- Classification Date
- June 27, 2016
- Termination Date
- August 16, 2016
- Address
- 1225 Old Hwy 8 NW, Saint Paul, MN, 55112-6416, United States
Description
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.
Reason
The pouch label was missing the use by date (UBD) of 2018-04.
Code Info
Lot #160877, UDI Number: (01)10852528005084(17)180430(10)160877.
Distribution
US Nationwide distribution.
Quantity
190 units (38 - 5 pack shelf cartons)