Device 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.
Z-2640-2014
Product summary
- Event
- Event 69083
- Status
- Terminated
- Classification
- Class II
- Quantity
- 116,633 units
- Official record key
device-enforcement:Z-2640-2014
Official wording
Reason: Not approved labeling claims (antimicrobial and autolytic debridement)
Code information: Lot codes: JCA0086 through JCA0106.
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)