Home / Recalls / Codman & Shurtleff, Inc. / Z-1572-2014

Z-1572-2014 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
May 21, 2014
Initiation Date
November 10, 2015
Termination Date
November 10, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
34

Product Description

MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 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.

Reason for Recall

A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.

Distribution Pattern

Worldwide Distribution including the countries of Belgium Germany, Spain, United Kingdom, Ireland, Italy, Russia and Turkey.

Code Information

Serial Numbers: NNBLV3, NNBLHF, NNBLK4, NNBLV4, NNBLV6, NPBL9F, NPBL89, NPBL8R, NPBL8T, NPBL9B, NPBL77, NPBL2K, NPBL8V, NPBL9D, NPBL8C, NNBLHH, NNBLHD, NNBLHB, NNBLHJ, NNBLHC, NNBLHG, NNBLV7, NNBLV5, NNBLV0, NNBLWC, NPBL2G, NPBL1F, NPBL1D, NPBL1B, NPBL09, NPBL88, NPBL7R, NPBL2N, NPBL6Z

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-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-2189-2014 Class II — Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories (July 3, 2014)
  • Z-2190-2014 Class II — Codman Certas - In Line Valve with SIPHONGUARD¿, Unitized Catheter and Accessori (July 3, 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)