Recall Z-1691-2013 ยท LKK Pump, Infusion, Implanted, Programmable
Codman & Shurtleff, Inc.
MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of Baclofen or Morphine Product Code: 91-4201US (40ml pump) 91-4201 (40ml pump) Intended for the intrathecal delivery of Baclofen or Morphine.
| Date | Jul 16, 2013 (initiated Jun 7, 2013) |
| Status | Terminated |
| Reason | Miscalibrated Fill Level Sensor may affect dosing level |
| Root cause | Device Design |
| 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 misca |
| Quantity | 5 US and and 360 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.