Recall Z-2051-2016— Cardiovascular Systems Inc

Name: FDA recall Z-2051-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-13

Class II · Terminated

Class II FDA medical device recall by Cardiovascular Systems Inc, initiated 2016-06-13, terminated 2016-08-16. It names one FDA 510(k) clearance: K090521. 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.. Reason: The pouch label was missing the use by date (UBD) of 2018-04..

Recalling firm: Cardiovascular Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2016-06-13
Terminated: 2016-08-16
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K090521 — DIAMONDBACK 360 DBXCardiovascular Systems, Inc.·cleared 2009-03-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.