FDA (Devices) recall action 90999
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.
An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.
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.
Caire, Inc. is recalling CAIRE Liberator 20 liquid oxygen system units due to weld penetration inconsistencies discovered during an FDA audit. The manufacturing defect affects 3 units.
Caire, Inc. is recalling five CAIRE Liberator 30 liquid oxygen system units due to weld defects on the inner bottle that could lead to device failure and loss of oxygen supply to dependent patients.
Caire Inc. is recalling 70 CAIRE Liberator 45 liquid oxygen systems due to inconsistencies in weld penetration on the inner bottle's longitudinal weld seam discovered during an audit.
Caire, Inc. is recalling 10 CAIRE Liberator 45 liquid oxygen system units due to inconsistencies in weld penetration on the inner bottle discovered during an FDA audit.