CARDINAL HEALTH
Cardinal Health 200, LLC · Model HG3OZ · UDI-DI 00888499001360
Description
Hydrogel Partial to full thickness wounds: -Pressure and stasis ulcers -First- and second-degree burns -Lacerations, cuts, and abrasions -Post-operative incisions -Skin irritations Excellent viscosity Clean, greaseless formulation Cardinal Health Hydrogel is a clean, greaseless hydrogel used for the maintenance of a moist wound environment. Indications: May be used for the management of dry to lightly exuding, partial and full thickness wounds, including pressure and stasis ulcers, first- and second-degree burns, lacerations, cuts, abrasions, skin irritations, post-operative incisions, and conditions with periostomal care. Directions for use: Cleanse wound with appropriate wound cleanser such as Cardinal Health Wound Cleanser. Apply gel approximately 1/4-inch thick to wound bed. Cover with an appropriate secondary dressing. Repeat as often as necessary to keep wound moist. Ingredients: Water, aloe barbadensis leaf juice, glycerin, sorbitol, carbomer, triethanolamine, allantoin, methylparaben, disodium EDTA, imidazolidinyl urea Caution: For external use only. Avoid contact with eyes. If condition worsens or does not improve within 10 to 14 days, consult a physician. In rare instances of local sensitivity, discontinue use. Keep this and all similar products out of the reach of children. If swallowed, seek medical attention or contact a poison control center immediately. Follow directions for use. Store at ambient temperature.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-03-03 | Covidien LLC | Product sterility is compromised due to breach of sterile barrier |
| 2015-03-26 | PhotoMedex, Inc. | The labeling for the Iamin family of medical devices (e.g. printed and internet text) is not consistent with the intended uses and limitations identified at the time of the clearan |
| 2015-02-25 | Amerx Health Care Corp. | Nonapproved labeling claims (Sterile) |
| 2014-09-26 | Amerx Health Care Corp. | Formulation deviation |
| 2014-09-26 | Amerx Health Care Corp. | Formulation deviation |
| 2014-09-26 | Amerx Health Care Corp. | Formulation deviation |
| 2014-09-26 | Amerx Health Care Corp. | Formulation deviation |
| 2014-07-11 | Amerx Health Care Corp. | Not approved labeling claims (antimicrobial and autolytic debridement) |
| 2014-07-11 | Amerx Health Care Corp. | Not approved labeling claims (antimicrobial and autolytic debridement) |
| 2014-07-11 | Amerx Health Care Corp. | Not approved labeling claims (antimicrobial and autolytic debridement) |
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