Recall Z-2296-2013— Codman & Shurtleff, Inc.
Class I · Terminated
Class I FDA medical device recall by Codman & Shurtleff, Inc., initiated 2013-08-13, terminated 2014-09-11. FDA's recall record names no specific 510(k) clearance for this event. Product: MedStream Refill Kit (1 unit), EMEA: 91-4289 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.. Reason: Drug flow rates exceeding programmed flow rates..
- Recalling firm
- Codman & Shurtleff, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2013-08-13
- Terminated
- 2014-09-11
- Firm location
- Raynham, MA, United States
Product description
MedStream Refill Kit (1 unit), EMEA: 91-4289 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.
Reason for recall
Drug flow rates exceeding programmed flow rates.
Data sourced from openFDA. This site is unofficial and independent of the FDA.