Device product
Amerigel Hydrogel Wound Dressing Wound management
Z-0497-2015
Product summary
- Event
- Event 69394
- Status
- Terminated
- Classification
- Class II
- Quantity
- 340,896
- Official record key
device-enforcement:Z-0497-2015
Official wording
Reason: Formulation deviation
Code information: Model # A2001, Lot #s: YWD13, YWD15, YWD16, 2WD01, 2WD02, 2WD03, 2WD04, 2WD05, 2WD08, 2WD09, 2WD11, 2WD13, 2WD14, 2WD15, 2WD17, 2WD18, 3WD01, 3WD02, 3WD03, 3WD04, 3WD05
Distribution pattern: Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, 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, WV, Virgin Islands, Puerto Rico, Guam, Hawaii and District of Columbia and Internationally to: Canada, England, Africa, and Australia.
Derived failure modes
-
Unknown
Formulation deviation