Device Recall Centrica

Lot #: 28090403, 03-0085, 03-0086, C030401

Gastroenterology-Urology Devices

2

No

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.

Sanarus brand Centrica¿ Rotational Core Biopsy medical device, Model/Product Code: CD-0500 (single Device); CD-1000 (5 pack)