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
___________________________________
