Recall Z-1691-2013— Codman & Shurtleff, Inc.
Class I · Terminated
Class I FDA medical device recall by Codman & Shurtleff, Inc., initiated 2013-06-07, terminated 2015-04-21. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Miscalibrated Fill Level Sensor may affect dosing level.
- Recalling firm
- Codman & Shurtleff, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2013-06-07
- Terminated
- 2015-04-21
- Firm location
- Raynham, MA, United States
Product description
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.
Reason for recall
Miscalibrated Fill Level Sensor may affect dosing level
Data sourced from openFDA. This site is unofficial and independent of the FDA.