MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) US 91-4200. Intended for the intrathecal delivery of Baclofen or Morphine.
FDA Recall Z-1690-2013 · Posted 2013-07-16
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Recalling FirmCodman & Shurtleff, Inc.
Recall StatusTerminated
Product CodeLKK
Date Initiated2013-06-07
Date Terminated2015-04-21
Product Quantity2 units US and 735 OUS
Reason for Recall
Miscalibrated Fill Level Sensor may affect dosing level
Firm Action
Codman issued a Medical Device Correction Notification to Medical Facilities dated June 7, 2013 via FedX to inform them of the potential problem and a Worksheet (instructions) to Identify Pumps with Miscalibrated FLS during each patient's next scheduled refill session or sooner if patient is symptomatic.
If a pump is identified as having a miscalibrated FLS, notify Codman Neuro using the same worksheet. In addition a sample letter was provided to Physi cans to provide to patients on the system.
Follow the recommendations for managing patients who are identified as having a pump with a miscalibrated FLS.
For additional information,contact your Codman Neuro representative, or 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution-USA (nationwide) including the states of FL, NC, NJ, and TX, and the countries of Austria, Belgium, Spain, Great Britain, Germany, Italy, Ireland, Luxemburg, Russia, Saudi Arabia, Portugal, Greece, Egypt, Switzerland, and Turkey.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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