Codman MedStream Infusion Pump Recalled for Miscalibrated Fill Level Sensor
Codman & Shurtleff is recalling MedStream Programmable Infusion Pumps because a miscalibrated fill level sensor may affect dosing levels.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
Codman & Shurtleff, Inc. is recalling the MedStream Programmable Infusion Pump, an implantable device intended for the intrathecal delivery of Baclofen or Morphine. The recall is due to a miscalibrated fill level sensor that may affect the dosing level of the medication.
The recall involves 2 units in the United States and 735 units outside the United States. The affected products were distributed worldwide, including nationwide in the US and in countries such as Austria, Belgium, Spain, Great Britain, Germany, Italy, Ireland, Luxemburg, Russia, Saudi Arabia, Portugal, Greece, Egypt, Switzerland, and Turkey. All serial numbers are included in this recall.
Patients using these devices should contact their healthcare provider for instructions on how to proceed. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the device could cause serious adverse health consequences or death.
The recalled product
- Product
- MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) US 91-4200. Intended for the intrathecal delivery of Baclofen or Morphine.
- Manufacturer
- Codman & Shurtleff, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers
Distribution
Part of a larger recall action
This product is one of 2 recalled by Codman & Shurtleff, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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