Recall Z-2028-2009 ยท MCW Catheter, Peripheral, Atherectomy
Cardiovascular Systems, Inc.
Diamondback 360 Orbital Atherectomy Device, 1.50 LT Classic, Model #DB-150L, CSI Part # 70025-02 Expiration 2012-02, Sterilized with Ethylene Oxide , Cardiovascular Systems, Inc., St. Paul, MN USA. The Diamondback 360 OAD are used with CSI's orbital atherectomy system in patients with arterial disease.
| Date | Sep 10, 2009 (initiated Apr 16, 2009) |
| Status | Terminated |
| Reason | CSI is correcting (8) packages of Diamondback 360 due to a missing "Use By Date" on the device labeling. The labelling should have been a 12 month shelf life (2010-02) rather than no information for shelf life. The units affected by this correction are sterilized products, and CSI believes that there is no immediate risk to health associated with these distributed products recognizing the valid s |
| Root cause | Incorrect or no expiration date |
| Action | Cardiovascular System, Inc. issued an "URGENT: Medical Device Correction" letter dated April 16, 2009. The letter described the product and the problem. The letter informed the consignees that the "Device" re-labeling would be performed by company representatives. Devices will not be returned. For further information, contact Cardiovascular System, Inc. 1-877-274-0901. |
| Quantity | 8 |
| Distribution | Nationwide Distribution -- CA, GA, MI, NY, NY and TN. |
| FDA record | Open on fda.gov |