Amerigel Wound Dressing Maximum Strength CAT# A2001. recall: Labeling Error
Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management.
Why was Amerigel Wound Dressing Maximum Strength CAT# A2001. recalled?
Not approved labeling claims (antimicrobial and autolytic debridement)
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?
Lot codes: 3WD02, 3WD03, 3WD04, and 3WD05
- Product
- Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management.
- Recalling firm
- Amerx Health Care Corp.
- Quantity
- 382,620 units
- Distribution
- Worldwide Distribution-USA (nationwide) including the District of Columbia, Virgin Islands, Puerto Rico, and Guam, and the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, and WV, and the countries of Canada, England, Africa, and Australia.
- Recall date
- September 24, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)