Home / Recalls / Codman & Shurtleff, Inc. / Z-2298-2013

Z-2298-2013 Class I Terminated

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

Recall Details

Product Type
Devices
Report Date
October 9, 2013
Initiation Date
August 13, 2013
Termination Date
September 11, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
0 - product used for internal training purposes only

Product Description

MedStream Refill Kit, U.S (6 units): 91-4288 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir.

Reason for Recall

Drug flow rates exceeding programmed flow rates.

Distribution Pattern

Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK.

Other recalls by Codman & Shurtleff, Inc.

  • Z-2280-2019 Class II — GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm). (May 16, 2019)
  • Z-1572-2014 Class II — MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStr (November 10, 2015)
  • 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-0090-2015 Class II — Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage Syste (September 15, 2014)
  • Z-0089-2015 Class II — Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System (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-2184-2014 Class II — Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas (July 3, 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)