Device product
Amerigel Post-op Surgical Kits Wound management
Z-0498-2015
Product summary
- Event
- Event 69394
- Status
- Terminated
- Classification
- Class II
- Quantity
- 79,677
- Official record key
device-enforcement:Z-0498-2015
Official wording
Reason: Formulation deviation
Code information: Model # A2002, Lot #s: JCA0086, JCA0087, JCA0088, JCA0089, JCA0090, JCA0091, JCA0092, JCA0093, JCA0094, JCA0095, JCA0096, JCA0097, JCA0098, JCA0099, JCA0100, JCA0101, JCA0102, JCA0103, JCA0104, JCA0105, JCA0106
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