medical Class II Updated 2024-01-24

Smiths Medical Asd Inc recalls 20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number

Recalled Product

20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR


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

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number: 4398428 4404690
View official government recall

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