FDA (Devices) recall action 83527
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Intersurgical Inc is recalling 115,200 Double Swivel Elbow airway connectors because the port may crack and leak.
Intersurgical Inc is recalling 46,450 Double Swivel Elbow airway connectors because the port may crack and leak.
Intersurgical Inc is recalling 50,400 airway connectors because the swivel elbow port may crack and leak. The recall covers products distributed nationwide in the US.
Intersurgical Inc is recalling 19,200 airway connectors because the swivel elbow port may crack and leak.