Diamondback 360 Orbital Atherectomy Device, 1.50 LT Classic, Model #DB-150L, CSI Part # 70025-02 Expiration 2012-02, Ste
FDA device recall Z-2028-2009 · posted 2009-09-10 · Terminated
Recall details
- Recalling firm
- Cardiovascular Systems, Inc.
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Incorrect or no expiration date
- Status
- Terminated
- Product code
- MCW
- Quantity affected
- 8
- Distribution
- Nationwide Distribution -- CA, GA, MI, NY, NY and TN.
- Date initiated
- 2009-04-16
- Date posted
- 2009-09-10
- Date terminated
- 2011-12-10
- Location
- Arden Hills, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIAMONDBACK 360 DBX (K090521) | Cardiovascular Systems, Inc. | 2009-03-20 |
| DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS (K071427) | Cardiovascular Systems, Inc. | 2007-08-30 |