Codman MedStream Programmable Pump Recalled for Excessive Drug Flow Rates
Codman & Shurtleff, Inc. is recalling 369 MedStream Programmable Pumps because they may deliver drug flow rates exceeding programmed levels.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Codman & Shurtleff, Inc. is recalling 369 units of the MedStream Programmable Pump (40ml Pump EMEA 91-4201). The recall is due to a defect where the device 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 in the United States (NJ, NC, TX, FL) and in Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxembourg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and the UK.
Patients and healthcare providers should contact their healthcare provider or the recalling firm for instructions on how to manage the affected devices.
The recalled product
- Product
- MedStream Programmable Pump; 40ml Pump EMEA 91-4201 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
- 369
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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