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07-23-2013, 08:09 PM #1
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- Aug 2012
- Merced, CA 95348-1422
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Recall: MedStream Programmable Infusion Pump
MedStream Programmable Infusion Pump
Recall Class: Class I
Date Recall Initiated: June 7, 2013
Products: MedStream Programmable Infusion Pump
Models: 91-4200US 20 ml pump, .91-4201US 40 ml pump, 91-4200 20 ml pump, 91-4201 40 ml pump
These affected products were distributed from July, 2009 through June, 2013.
Use: The MedStream Programmable pump is an implanted device intended for the intrathecal delivery of the drug Baclofen.
Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham, MA 02767
Medos International SARL
CH 2400 Le Locle, Switzerland
Reason for Recall: The Fill Level Sensor (FLS), a component of the Medstream Programmable Infusion Pump, may malfunction. The Fill Level Sensor is intended to measure the contents of the pump drug reservoir. The malfunction in the Fill Level Sensor may cause the pumpís low reservoir alarm, normally set at 3 ml, to sound too early or too late. The recommended pump refill date, computed by the Control Unit, may be incorrect. A late sounding alarm could result in a pump not being refilled in time, which could result in the under delivery or discontinuation of medications like Baclofen. This could result in serious medical illness or death.
Public Contact: For questions about this action contact Codman Neuro Clinical Support at 1-800-660-2660. Please report any malfunction or adverse event related to this device to Codman Neuro at 1-866-491-0974, option 2.
FDA District: New England District Office