Device product
Amerigel Saturated Gauze Dressing Wound management
Z-0500-2015
Product summary
- Event
- Event 69394
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21,108
- Official record key
device-enforcement:Z-0500-2015
Official wording
Reason: Formulation deviation
Code information: Model # A5002, Lot #s: 05368, 05345, 09282, 10295, 12201, 12303, 12322, 12328, 13100, 13115, 13180
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