Recall Z-1468-2014
Codman & Shurtleff, Inc. · initiated December 13, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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, Catheter and Accessories 82-8806 In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories 82-8807 In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and Accessories 82-8850 Certas Therapeutic Management System
Codes / lots: All serial numbers
Reason for recall
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.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1468-2014
- Initiated
- December 13, 2013
- Posted by FDA
- April 17, 2014
- Terminated
- April 21, 2016
- Product code
- JXG – Shunt, Central Nervous System And Components
- Quantity
- 9,445 units
- Distribution
- Nationwide Distribution.
- Recalling firm
- Codman & Shurtleff, Inc., Raynham, MA