Recall Z-2051-2016 ยท MCW Catheter, Peripheral, Atherectomy
Cardiovascular Systems Inc
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.
| Date | Jun 13, 2016 |
| Status | Terminated |
| Reason | The pouch label was missing the use by date (UBD) of 2018-04. |
| Root cause | Process control |
| Action | Consignees were sent on 6/13/16 a Cardiovascular Systems, Inc. "Urgent Correction" letter date June 10, 2016. The letter described the problem and the affected product. Advised consignees to set affected product aside for their sales representative which will be applying the correct pouch label to the affected product. Requested consignees to fill and sign the Customer Acknowledgement Form that the sales representative will be presenting to them. For questions contact Quality at Cardiovascular Systems, Inc. 1-651-259-2068 1225 Old Highway 8 NW Saint Paul, MN 55112. |
| Quantity | 190 units (38 - 5 pack shelf cartons) |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090521 | DIAMONDBACK 360 DBX Cardiovascular Systems, Inc., Mar 20, 2009 |