Device product
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.
Z-2300-2013
Product summary
- Event
- Event 65821
- Status
- Terminated
- Classification
- Class I
- Quantity
- 735 units
- Official record key
device-enforcement:Z-2300-2013
Official wording
Reason: Drug flow rates exceeding programmed flow rates.
Code information: OUS: Per recall strategy
Distribution pattern: 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.
Derived failure modes
-
Unknown
Drug flow rates exceeding programmed flow rates.