MedStream Refill Kit Recalled for Excessive Drug Flow Rates
Codman & Shurtleff is recalling MedStream Refill Kits because they may allow drug flow rates to exceed 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 Class I, and the rubric mandates a score of at least 4 for FDA Class I recalls. The hazard involves a structural/functional defect in a medical device that could lead to significant injury.
Plain-English summary
Codman & Shurtleff, Inc. is recalling MedStream Refill Kits (1 unit) 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 involves 2,168 units 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.
Consumers and healthcare providers should contact Codman & Shurtleff, Inc. for further instructions regarding the recall and potential replacement or repair of the affected units.
The recalled product
- Product
- MedStream Refill Kit (1 unit), EMEA: 91-4289 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.
- Affected units
- 2,168
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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