FDA (Devices) recall action 71023
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.
Chest drains have a missing o-ring
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.
Atrium Medical Corporation is recalling Oasis Dry Suction Water Seal Chest Drains because they have a missing o-ring. The recall covers 1,170 cases distributed nationwide and in Canada and Germany.
Atrium Medical Corporation is recalling EXPRESS Dry Seal Chest Drains because they have a missing o-ring. The recall affects 390 cases distributed in the US, Canada, and Germany.
Atrium Medical Corporation is recalling Ocean Water Seal Chest Drains because they have a missing o-ring. The recall covers 130 cases distributed nationwide and in Canada and Germany.
Atrium Medical Corporation is recalling Ocean Water Seal Chest Drains because they have a missing o-ring. The recall covers 390 cases distributed nationwide, in Canada, and in Germany.