Recall Z-1571-2014 ยท LKK Pump, Infusion, Implanted, Programmable
Codman & Shurtleff, Inc.
MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.
| Date | May 9, 2014 (initiated Nov 10, 2015) |
| Status | Terminated |
| Reason | A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life. |
| Root cause | Device Design |
| Action | Codman Neuro sent an Urgent Field Safety Notice to all affected customers on April 18, 2014. The letter identified the product the problem and the action needed to be taken by the customer. The letter states the reason for recall, information about managing patients with affected pumps, and returning affected non-implanted pumps. You are receiving this voluntary recall notification because our records indicate that you are the recipient of one or more MedStream Pumps affected by this recall. Please do not implant any identified products included in this recall. Please complete the enclosed A |
| Quantity | 90 |
| Distribution | Worldwide Distribution including the countries of Belgium Germany, Spain, United Kingdom, Ireland, Italy, Russia and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.