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Codman & Shurtleff, Inc. recalls MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-
Recalled July 24, 2013 · FDA recall Z-1690-2013 · Codman & Shurtleff
Hazard
Miscalibrated Fill Level Sensor may affect dosing level · FDA Class I
Units
2 units US and 735 OUS
Sold at
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.
Description
Miscalibrated Fill Level Sensor may affect dosing level
Product
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.
Manufacturer(s)
Codman & Shurtleff, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →