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Recall Observatory FDA recall evidence

Device 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.

Z-1690-2013

June 07, 2013

Class I

Product summary

Firm
Codman & Shurtleff, Inc.
Event
Event 65420
Status
Terminated
Classification
Class I
Quantity
2 units US and 735 OUS
Official record key
device-enforcement:Z-1690-2013

Official wording

Reason: Miscalibrated Fill Level Sensor may affect dosing level

Code information: All serial numbers

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Miscalibrated Fill Level Sensor may affect dosing level