Device product
Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management.
Z-2641-2014
Product summary
- Event
- Event 69083
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,740 units
- Official record key
device-enforcement:Z-2641-2014
Official wording
Reason: Not approved labeling claims (antimicrobial and autolytic debridement)
Code information: Lot codes: 2WD07.
Distribution pattern: 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.
Derived failure modes
-
Unknown
Not approved labeling claims (antimicrobial and autolytic debridement)