Home / Recalls / Codman & Shurtleff, Inc. / Z-1468-2014

Z-1468-2014 Class II Terminated

Recalled by Codman & Shurtleff, Inc. — Raynham, MA

Recall Details

Product Type
Devices
Report Date
April 23, 2014
Initiation Date
December 13, 2013
Termination Date
April 21, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9,445 units

Product Description

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

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.

Distribution Pattern

Nationwide Distribution.

Code Information

All serial numbers

Other recalls by Codman & Shurtleff, Inc.

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  • Z-1571-2014 Class II — MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStr (November 10, 2015)
  • Z-1684-2015 Class II — CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODM (March 5, 2015)
  • Z-0089-2015 Class II — Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System (September 15, 2014)
  • Z-0090-2015 Class II — Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage Syste (September 15, 2014)
  • Z-0091-2015 Class II — Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) C (September 15, 2014)
  • Z-2191-2014 Class II — Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Unitized BACTISEAL¿ Cath (July 3, 2014)
  • Z-2189-2014 Class II — Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories (July 3, 2014)
  • Z-2184-2014 Class II — Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas (July 3, 2014)