Amerigel Hydrogel Gauze Dressing 2 x 2 recall: Labeling Error
Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.
Why was Amerigel Hydrogel Gauze Dressing 2 x 2 recalled?
Nonapproved labeling claims (Sterile)
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
ALL Lots - 11406, 11414, 12439, 12466, and 02521.
- Product
- Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.
- Recalling firm
- Amerx Health Care Corp.
- Quantity
- 6,491 units
- Distribution
- Worldwide Distribution -- US, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WY and Hawaii; and, the countries of Canada and Bahrain.
- Recall date
- June 24, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)