MedStream Refill Kit Recalled for Excessive Drug Flow Rates
Codman & Shurtleff 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 source text explicitly identifies this as a Class I recall, which meets the rubric criteria for a Critical severity score (5).
Plain-English summary
Codman & Shurtleff, Inc. is recalling MedStream Refill Kits (U.S. product number 91-4287) due to a defect where drug flow rates may exceed 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 recall affects 5 units of the MedStream Refill Kit, specifically lot/serial number 13B090CT. The product was distributed worldwide, including nationwide in the United States in the states of New Jersey, North Carolina, Texas, and Florida, as well as in Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxembourg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and the United Kingdom.
This is a Class I recall, which indicates a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death. Users should contact their healthcare provider or the manufacturer for instructions on how to proceed.
The recalled product
- Product
- MedStream Refill Kit, U.S: 91-4287 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 the…
- Manufacturer
- Codman & Shurtleff, Inc.
- Hazard
- Affected units
- 5
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)
- Lot/Serial Number US: 13B090CT
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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