Medex Injection Line Rotating Adapter Recalled Due to O-Ring Defect
Smiths Medical is recalling Medex injection line rotating adapters due to a manufacturing defect where the O-ring inner diameter may be oversized, potentially causing medication leaks during infusion.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a medical device with a manufacturing defect affecting seal integrity, a critical safety component. While no illnesses or injuries have been reported, the potential for medication under-infusion during critical therapy represents a risk-of-harm scenario per the recall rubric.
Plain-English summary
Smiths Medical Asd Inc. is recalling the Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R, Lot Number 4398433. A total of 31,685 units have been distributed worldwide to the United States, Canada, and the United Arab Emirates.
A manufacturing defect affects the rotating mechanism in this product. The inner diameter of the O-ring may be oversized, compromising seal integrity. This defect may result in a leak during medication infusion, potentially leading to under-infusion of medication.
This is a Class II recall issued by the U.S. Food and Drug Administration.
The recalled product
- Product
- Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R
- Manufacturer
- Smiths Medical Asd Inc
- Hazard
- manufacturing-defect
- seal-defect
- medication-leak
- under-infusion
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 Number: 4398433
Distribution
Distributed nationwide across the United States.
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