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Smiths Medical Asd Inc recalls Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R
Recalled January 24, 2024 · FDA recall Z-0742-2024 · Smiths Medical Asd
Hazard
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. · FDA Class II
Units
31,685 total
Sold at
Worldwide distribution - US Nationwide and the countries of Canada, UAE.
Description
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.
Product
Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R
Manufacturer(s)
Smiths Medical Asd Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →