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.
This recall has been terminated (originally issued July 16, 2013).
- Company
- Codman & Shurtleff, Inc.
- Recall Initiated
- June 7, 2013
- Posted
- July 16, 2013
- Terminated
- April 21, 2015
- Recall Number
- Z-1690-2013
- Quantity
- 2 units US and 735 OUS
- Firm Location
- Raynham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Miscalibrated Fill Level Sensor may affect dosing level
Distribution
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.
Lot / Code Info
All serial numbers
Root Cause
Device Design
Action Taken
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.