Recall Z-1468-2014 ยท JXG Shunt, Central Nervous System And Components
Codman & Shurtleff, Inc.
CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801 In Line Valve with Catheter and Accessories 82-8802 In Line Valve with Unitized Catheter and Accessories 82-8803 In line Valve with Unitized BACTISEAL Catheter and Accessories 82-8804 In Line Valve only with SIPHONGUARD Device 82-8805 In Line Valve with SIPHONGUARD Device, Cathe
| Date | Apr 17, 2014 (initiated Dec 13, 2013) |
| Status | Terminated |
| Reason | Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and the location and orientation of implanted CODMAN CERTAS Programmable Valves. |
| Root cause | Process control |
| Action | Codman Neuro issued notification packages dated 12/13/13 to Domestic Hospitals and international accounts. Specific letters and associated inclusion of the additional aids, include A) a valve setting verification guide with instructions for use with x-ray images, and B) a plastic valve cut out overlay). A response reply form was included to be completed and returned to confirm effectiveness of the notification. |
| Quantity | 9,445 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |