Medical Device Recall: Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R
Smiths Medical Asd Inc · November 10, 2023
Reason for Recall
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, UAE.
States Affected
NATIONWIDE
Quantity Affected
31,685 total
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0742-2024
Status: ongoing
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