Recall Z-2297-2013 ยท LKK Pump, Infusion, Implanted, Programmable
Codman & Shurtleff, Inc.
MedStream Refill Kit (6 units), EMEA: 91-4290 Product Usage: 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. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir.
| Date | Sep 30, 2013 (initiated Aug 13, 2013) |
| Status | Terminated |
| Reason | Drug flow rates exceeding programmed flow rates. |
| Root cause | Use error |
| Action | Codman & Shurtleff, Inc. sent a Medical Device Field Safety Notice letter dated August 13, 2013 to US Consignees via FedEx overnight delivery and International Consignees were notified of the recall via email. The letter identifed the affected products, potential clinical impact, and updated IFU pump filling warning. The letter informed consignees that the Instructions for Use (IFU) and product training materials had been updated by adding a warning statement about potential over infusion if air gets inside the pump reservoir and additional clarifications to reinforce the proper filling tech |
| Quantity | 832 units |
| Distribution | Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.