Recall Z-0935-03 ยท KNW Instrument, Biopsy
Sanarus Medical Inc
Sanarus brand Centrica Rotational Core Biopsy medical device, Model/Product Code: CD-0500 (single Device); CD-1000 (5 pack)
| Date | Jun 12, 2003 (initiated May 13, 2003) |
| Status | Terminated |
| Reason | Recent 'pre-tests' show that Argon gas has the potential to escape from the device during a biopsy procedure. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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 the user level; i.e., clinics, hospitals and medical centers who received the recalled product. Th |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022879 | MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY Sanarus Medical, Inc., Sep 23, 2002 |