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FDANovember 10, 2023device

Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

smiths medical asdsmithssmiths medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R — Recall Details · AllClear