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Recall Observatory FDA recall evidence

Device product

MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 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.

Z-1572-2014

November 10, 2015

Class II

Product summary

Firm
Codman & Shurtleff, Inc.
Event
Event 67921
Status
Terminated
Classification
Class II
Quantity
34
Official record key
device-enforcement:Z-1572-2014

Official wording

Reason: A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.

Code information: Serial Numbers: NNBLV3, NNBLHF, NNBLK4, NNBLV4, NNBLV6, NPBL9F, NPBL89, NPBL8R, NPBL8T, NPBL9B, NPBL77, NPBL2K, NPBL8V, NPBL9D, NPBL8C, NNBLHH, NNBLHD, NNBLHB, NNBLHJ, NNBLHC, NNBLHG, NNBLV7, NNBLV5, NNBLV0, NNBLWC, NPBL2G, NPBL1F, NPBL1D, NPBL1B, NPBL09, NPBL88, NPBL7R, NPBL2N, NPBL6Z

Distribution pattern: Worldwide Distribution including the countries of Belgium Germany, Spain, United Kingdom, Ireland, Italy, Russia and Turkey.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.