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Cardiovascular Systems Inc recalls ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part number 72023-02, Model Number VPR
Recalled July 6, 2016 · FDA recall Z-2051-2016 · Cardiovascular Systems
Hazard
The pouch label was missing the use by date (UBD) of 2018-04. · FDA Class II
Units
190 units (38 - 5 pack shelf cartons)
Sold at
US Nationwide distribution.
Description
The pouch label was missing the use by date (UBD) of 2018-04.
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.
Manufacturer(s)
Cardiovascular Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →