FDA (Devices) recall action 66788
The FDA (Devices) publishes a recall like this one as 9 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 9 pages.
Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
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 6,684 Ocean Water Seal Chest Drain ATS units because the chest drain tubing may leak or disconnect.
Atrium Medical Corporation is recalling Ocean Water Seal Chest Drain ATS Blood Recovery Systems because the tubing may leak or disconnect.
Atrium Medical Corporation is recalling 361 units of the Ocean Water Seal Chest Drain ATS Blood Recovery System because the tubing may leak or disconnect.
Atrium Medical Corporation is recalling Oasis Dry Suction Water Seal ATS Chest Drains because the tubing may leak or disconnect.
Atrium Medical Corporation is recalling 954 units of Oasis Dry Suction Water Seal ATS Chest Drains because the tubing may leak or disconnect.
Atrium Medical Corporation is recalling 1,944 units of Express Dry Seal ATS Chest Drains because the tubing may leak or disconnect.
Atrium Medical Corporation is recalling 1,002 units of Ocean Water Seal Chest Drain ATS Blood Recovery Systems due to potential tubing leaks or disconnections.
Atrium Medical Corporation is recalling 7,274 units of the Express Dry Seal ATS Chest Drain because the tubing may leak or disconnect.
Atrium Medical Corporation is recalling 624 units of Ocean Water Seal Chest Drain ATS Blood Recovery Systems because the tubing may leak or disconnect.