Codman MedStream Infusion Pump Recall for Low Battery Alarm Issue
Codman & Shurtleff is recalling 34 MedStream Programmable Infusion Pumps because they may trigger a low battery alarm at the beginning of the implanted life.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a functional alarm issue without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Codman & Shurtleff, Inc. is recalling 34 units of the MedStream Programmable Infusion Pump, 40 mL (Product Code: 91-4201). The recall covers specific serial numbers distributed worldwide, including Belgium, Germany, Spain, the United Kingdom, Ireland, Italy, Russia, and Turkey.
The recall is being conducted because a small number of these specific pumps may trigger a low battery alarm at the beginning of the implanted life. The device 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.
Patients with these specific implanted pumps should contact their healthcare provider or Codman & Shurtleff for further instructions regarding the device.
The recalled product
- Product
- MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 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.
- Manufacturer
- Codman & Shurtleff, Inc.
- Hazard
- Affected units
- 34
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 (20)
- Serial Numbers: NNBLV3
- NNBLHF
- NNBLK4
- NNBLV4
- NNBLV6
- NPBL9F
- NPBL89
- NPBL8R
- NPBL8T
- NPBL9B
- NPBL77
- NPBL2K
- NPBL8V
- NPBL9D
- NPBL8C
- NNBLHH
- NNBLHD
- NNBLHB
- NNBLHJ
- NNBLHC
Distribution
Distribution scope not specified by the agency.
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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