FDAAugust 7, 2019device

Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031. Airway connector.

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

The hazard

The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.

What to do

FDA enforcement status: Terminated

Brands named

intersurgical

Recall history

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

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