MedStream Refill Kit Recalled for Excessive Drug Flow Rates
Codman & Shurtleff, Inc. is recalling MedStream Refill Kits 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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Codman & Shurtleff, Inc. is recalling MedStream Refill Kits, U.S. (6 units), product code 91-4288. The recall is due to a defect where drug flow rates may exceed the programmed flow rates. 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. The Refill Kits are intended for use in the filling and re-filling of the Medstream pump reservoir.
The source text indicates that 0 units were distributed for commercial use, as the product was used for internal training purposes only. However, the distribution pattern lists worldwide distribution, including the USA (NJ, NC, TX, FL) and multiple international countries. No specific dates, lot numbers, or injury reports are provided in the source text.
Consumers and healthcare providers should contact Codman & Shurtleff, Inc. for further instructions regarding the recall. The FDA has classified this recall as Class I, indicating a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.
The recalled product
- Product
- MedStream Refill Kit, U.S (6 units): 91-4288 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 use in…
- Manufacturer
- Codman & Shurtleff, Inc.
- Hazard
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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