Sanarus brand Centrica Rotational Core Biopsy medical device, Model/Product Code: CD-0500 (single Device); CD-1000 (5 pa
FDA device recall Z-0935-03 · posted 2003-06-12 · Terminated
Recall details
- Recalling firm
- Sanarus Medical Inc
- Reason for recall
- Recent 'pre-tests' show that Argon gas has the potential to escape from the device during a biopsy procedure.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KNW
- Quantity affected
- 83 units
- 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
- Date initiated
- 2003-05-13
- Date posted
- 2003-06-12
- Date terminated
- 2003-09-15
- Location
- Pleasanton, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY (K022879) | Sanarus Medical, Inc. | 2002-09-23 |