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Smiths Medical Asd Inc recalls HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP
Recalled January 24, 2024 · FDA recall Z-0744-2024 · 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
HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP
Manufacturer(s)
Smiths Medical Asd Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →