Cl II MedStream Programmable Infusion Pump

Company: Codman & Shurtleff, Inc
Date of Enforcement Report:5/21/2014
Class lI:

PRODUCT

MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 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.
Recall Number Z-1571-2014

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

RECALLING FIRM/MANUFACTURER
Codman & Shurtleff, Inc on 4/18/2014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
90

DISTRIBUTION
Nationwide and Internationally

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