FDA (Devices) recall action 93343
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation.
The agency’s own wording, quoted from the enforcement report.
Atrium Oasis chest drain devices were re-sterilized by a third party using unapproved packaging and sterilization processes lacking manufacturer validation. Affected devices were distributed in Virginia.
Atrium Medical Corporation is recalling specific lots of Atrium Oasis Dry Suction Water Seal Chest Drains that were re-sterilized by a third party using unapproved methods and packaging. The invalid sterilization process lacks manufacturer validation and may compromise device sterility.