Sanarus brand Centrica Rotational Core Biopsy medical device, Model/Product Code: CD-0500 (single Device); CD-1000 (5 pack)
This recall has been terminated (originally issued June 12, 2003).
- Company
- Sanarus Medical Inc
- Recall Initiated
- May 13, 2003
- Posted
- June 12, 2003
- Terminated
- September 15, 2003
- Recall Number
- Z-0935-03
- Quantity
- 83 units
- Firm Location
- Pleasanton, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Recent 'pre-tests' show that Argon gas has the potential to escape from the device during a biopsy procedure.
Distribution
Product was released for distribution to 10 consignees. 83 units from the lot had been shipped to consignees. The U.S. States include: MD, TN, TX, OH, and IL. The recall was appropriately extended to the user level; i.e., clinics, hospitals and medical centers who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
Lot / Code Info
Lot #: 28090403, 03-0085, 03-0086, C030401
Root Cause
Other
Action Taken
On 5/13/03, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected devices and providing instructions on the recall.