Oct

2013

MedStream Programmable Pumps & refill kits Class I

Company: Codman & Shurtleff, Inc.
Date of Enforcement Report: 10/2/2013
Class l:

PRODUCT

MedStream Programmable Pump; 20ml – 91-4200US 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.

REASON
Drug flow rates exceeding programmed flow rates.

RECALLING FIRM/MANUFACTURER
Codman & Shurtleff, Inc., Raynham, MA on 8/13/2013. Voluntary: Firm Initiated recall is ongoing.

DISTRIBUTION
Nationwide and Internationally

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About the author

Amy Sellers

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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MedStream Programmable Pumps & refill kits Class I

Amy Sellers

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