FDAFDA · Food and drugs·Recall number Z-1690-2013
MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) US 91-4200. Intended for the intrathecal delivery of Baclofen or Morphine.
Published July 24, 2013 · Recall initiated: June 7, 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
Miscalibrated Fill Level Sensor may affect dosing level
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Codman & Shurtleff, Inc.
- Distributor
- Worldwide Distribution-USA (nationwide) including the states of FL, NC, NJ, and TX, and the countries of Austria, Belgium, Spain, Great Britain, Germany, Italy, Ireland, Luxemburg, Russia, Saudi Arabia, Portugal, Greece, Egypt, Switzerland, and Turkey.
- Lot
- All serial numbers
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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