FDA-Device2016-07-06Class II
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.
Cardiovascular Systems Inc
Hazard
The pouch label was missing the use by date (UBD) of 2018-04.
Sold states
US Nationwide distribution.
Affected count
190 units (38 - 5 pack shelf cartons)
Manufactured in
1225 Old Hwy 8 NW, Saint Paul, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2051-2016Don't want to check this manually?
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