FDA (Devices) recall action 93818
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
The agency’s own wording, quoted from the enforcement report.
AMD Medicom Inc. is recalling Henry Schein Criterion Level 3 Earloop Masks because they were produced on non-validated equipment not included in the initial product qualification.
Patterson Procedure Earloop Masks (ASTM Level 3, blue) are being recalled because units were produced on non-validated equipment. The recall affects 180 cases with lot numbers 2339 and 2342, distributed across six states.
AMD Medicom Inc. is recalling Henry Schein Criterion Anti-Fog Earloop Masks Level 3 (Blue) because the masks were produced on non-validated equipment not included in the product qualification process.