FDA (Devices) recall action 69083
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.
Not approved labeling claims (antimicrobial and autolytic debridement)
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 Daily Dressing Advanced 3-in-1 Hydrogel because the product labeling includes unapproved claims for antimicrobial and autolytic debridement.
Amerx Health Care Corp. is recalling Amergel Wound Dressing Maximum Strength because the product labeling contains unapproved claims regarding antimicrobial and autolytic debridement properties.
Amerx Health Care Corp. is recalling Amerigel Post-Op Surgical Kits because the product labeling contains unapproved claims regarding antimicrobial and autolytic debridement properties.
Amerx Health Care Corp. is recalling Amergel Hydrogel Saturated Gauze Dressing pads because the product labeling includes unapproved claims regarding antimicrobial and autolytic debridement properties.