MedStream Programmable Pump Recalled for Excessive Drug Flow Rates
Codman & Shurtleff, Inc. is recalling 735 MedStream Programmable Pumps because they may deliver drug flow rates exceeding programmed levels.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a score of 4 or higher.
Plain-English summary
Codman & Shurtleff, Inc. is recalling 735 units of the MedStream Programmable Pump, specifically the 20ml Pump EMEA 91-4200 model. The recall is due to a defect where the pumps may deliver drug flow rates that exceed the programmed flow rates.
The affected pumps are intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. The recall covers units distributed worldwide, including nationwide in the United States (specifically in NJ, NC, TX, and FL) and in various countries across Europe, the Middle East, and Asia.
Consumers and healthcare providers should stop using the affected pumps and contact Codman & Shurtleff, Inc. for instructions on how to proceed with the recall.
The recalled product
- Product
- MedStream Programmable Pump; 20ml Pump EMEA 91-4200 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
- Manufacturer
- Codman & Shurtleff, Inc.
- Hazard
- Affected units
- 735
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)
- OUS: Per recall strategy
Distribution
Part of a larger recall action
This product is one of 8 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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