FDA (Devices) recall action 69394
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.
Formulation deviation
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.
Amerx Health Care Corp. is recalling Amerigel Hydrogel Wound Dressing units due to a formulation deviation. The recall covers 340,896 units distributed nationwide and internationally.
Amerx Health Care Corp. is recalling 1,740 units of Amerigel Daily Dressing Packets due to a formulation deviation. The affected products were distributed nationwide and internationally.
Amerx Health Care Corp. is recalling 79,677 Amerigel Post-op Surgical Kits due to a formulation deviation. The affected kits were distributed nationwide and internationally.
Amerx Health Care Corp. is recalling 21,108 units of Amerigel Saturated Gauze Dressing due to a formulation deviation. The products were distributed nationwide and internationally.