FDAFDA · Food and drugs·Recall number Z-2300-2013
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.
Published October 9, 2013 · Recall initiated: August 13, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Drug flow rates exceeding programmed flow rates.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Codman & Shurtleff, Inc.
- Distributor
- 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.
- Lot
- OUS: Per recall strategy
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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