FDA-Device2013-07-24Class I
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.
Codman & Shurtleff, Inc.
Hazard
Miscalibrated Fill Level Sensor may affect dosing level
Sold states
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.
Affected count
2 units US and 735 OUS
Manufactured in
325 Paramount Drive, N/A, Raynham, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1690-2013Don't want to check this manually?
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