Recall Z-1571-2014— Codman & Shurtleff, Inc.

Name: FDA recall Z-1571-2014
Creator: U.S. Food and Drug Administration
Published: 2015-11-10

Class II · Terminated

Class II FDA medical device recall by Codman & Shurtleff, Inc., initiated 2015-11-10, terminated 2015-11-10. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life..

Recalling firm: Codman & Shurtleff, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-11-10
Terminated: 2015-11-10
Firm location: Raynham, MA, United States

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.