Medex 700PSI Stopcock with Rotator Recalled Due to Seal Defect
Smiths Medical is recalling Medex 700PSI stopcocks with rotators due to a manufacturing defect affecting the O-ring seal. The defect may cause medication leakage and under-infusion during patient treatment.
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 is an FDA Class II recall for a medical device with a manufacturing defect affecting seal integrity. The source text reports no illnesses, injuries, or hospitalizations, and the hazard is potential rather than realized. However, the defect poses a documented risk of harm through medication under-infusion during patient infusion therapy.
Plain-English summary
Smiths Medical Asd Inc is recalling the Medex 700PSI STOPCOCK W/ROTATOR (List Number MX4331R). The recall involves approximately 31,685 units.
The recalled devices have a manufacturing defect affecting the O-ring seal. The inner diameter of the O-ring may be oversized, compromising the seal integrity. An inadequate seal can lead to medication leakage during infusion, potentially resulting in under-infusion of medication to patients.
The affected product has been distributed in the United States nationwide, as well as in Canada and the United Arab Emirates. The recall applies to units with lot numbers 4355397, 4380735, 4387234, and 4404740.
Healthcare facilities and individuals who may have the recalled product should verify the lot numbers on their devices. Consult with a healthcare provider before discontinuing use of the product if it is currently in service. Any adverse events or product defects should be reported to the FDA.
The recalled product
- Product
- Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R
- Manufacturer
- Smiths Medical Asd Inc
- Hazard
- 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: 4355397 4380735 4387234 4404740
Distribution
Distributed nationwide across the United States.
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