Recall Z-1690-2013
Codman & Shurtleff, Inc. · initiated June 7, 2013
Class I – dangerous or defective products that could cause serious health problems or death
Product
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.
Codes / lots: All serial numbers
Reason for recall
Miscalibrated Fill Level Sensor may affect dosing level
FDA-determined 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.
Details
- Recall number
- Z-1690-2013
- Initiated
- June 7, 2013
- Posted by FDA
- July 16, 2013
- Terminated
- April 21, 2015
- Product code
- LKK – Pump, Infusion, Implanted, Programmable
- Quantity
- 2 units US and 735 OUS
- 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.
- Recalling firm
- Codman & Shurtleff, Inc., Raynham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1691-2013 Class I | MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of…Miscalibrated Fill Level Sensor may affect dosing level | 06/07/2013Terminated |