Medical device recalls Moderate risk

Cardiovascular Systems Inc recalls ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part number 72023-02, Model Number VP…

Recall date
June 13, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2051-2016
FDA classification
Class II
Brand / firm
Cardiovascular Systems Inc
Sold / distributed
US Nationwide distribution.

Why it was recalled

The pouch label was missing the use by date (UBD) of 2018-04.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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