21
May
2014

Cl II MedStream Programmable Infusion Pump

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0

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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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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