The Recall Desk

FDA (Devices) recall action 69083

Amerx Health Care Corp. recalled 4 products on 2014-09-24

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.

Products
4
Announced
2014-09-24
Critical
0
Units
522,101

Why these products were recalled

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.

States named across these recalls

1–4 of 4

  • ModerateFDA (Devices)··2014-09-24

    Amerx Recalls Amerigel Post-Op Surgical Kits for Unapproved Labeling Claims

    Amerx Health Care Corp. is recalling Amerigel Post-Op Surgical Kits because the product labeling contains unapproved claims regarding antimicrobial and autolytic debridement properties.

    Product
    Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages CAT # A2002. Wound management.
    Category
    Distribution
    46 states
  • ModerateFDA (Devices)··2014-09-24

    Amerx Recalls Amergel Hydrogel Gauze Dressing for Unapproved Labeling Claims

    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.

    Product
    Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. Wound management.
    Category
    Distribution
    46 states
  • ModerateFDA (Devices)··2014-09-24

    Amerx Recalls Amerigel Daily Dressing for Unapproved Labeling Claims

    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.

    Product
    Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management.
    Category
    Distribution
    46 states
  • ModerateFDA (Devices)··2014-09-24

    Amerx Recalls Amergel Wound Dressing Due to Unapproved Labeling Claims

    Amerx Health Care Corp. is recalling Amergel Wound Dressing Maximum Strength because the product labeling contains unapproved claims regarding antimicrobial and autolytic debridement properties.

    Product
    Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management.
    Category
    Distribution
    46 states