Smiths Medical Asd Inc recalls 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Numbe
Recalled Product
48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
Hazard / Issue
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.
Issued by
FDA
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