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Recall Observatory FDA recall evidence

Device product

MedStream Refill Kit (6 units), EMEA: 91-4290 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-2297-2013

August 13, 2013

Class I

Product summary

Firm
Codman & Shurtleff, Inc.
Event
Event 65821
Status
Terminated
Classification
Class I
Quantity
832 units
Official record key
device-enforcement:Z-2297-2013

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

    reason.no_named_rule · v1.0.0

    Drug flow rates exceeding programmed flow rates.