Home / Recalls / Codman & Shurtleff, Inc. / Z-2300-2013

Z-2300-2013 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
735 units

Product Description

MedStream Programmable Pump; 20ml Pump EMEA 91-4200 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.

Code Information

OUS: Per recall strategy

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