Codman & Shurtleff, Inc. recalls MedStream Programmable Pump; 40ml - 91-4201US Usage: The Medstream programmable pump is intended for the intrathecal

Recalled October 9, 2013 · FDA recall Z-2294-2013 · Codman & Shurtleff

Hazard

Drug flow rates exceeding programmed flow rates. · FDA Class I

Units

5 units

Sold at

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.

Description

Drug flow rates exceeding programmed flow rates.

Product

MedStream Programmable Pump; 40ml - 91-4201US 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.

Manufacturer(s)

Codman & Shurtleff, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →