Z-2051-2016 Class II Terminated
FDA device recall Z-2051-2016 was initiated by Cardiovascular Systems Inc on June 13, 2016 and is designated Class II. Reason for recall: The pouch label was missing the use by date (UBD) of 2018-04. The recall status is terminated (terminated August 16, 2016). Affected quantity: 190 units (38 - 5 pack shelf cartons).
Recall Details
- Product Type
- Devices
- Report Date
- July 6, 2016
- Initiation Date
- June 13, 2016
- Termination Date
- August 16, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 190 units (38 - 5 pack shelf cartons)
Product 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 for Recall
The pouch label was missing the use by date (UBD) of 2018-04.
Distribution Pattern
US Nationwide distribution.
Code Information
Lot #160877, UDI Number: (01)10852528005084(17)180430(10)160877.