Device product
Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.
Z-1797-2015
Product summary
- Event
- Event 71161
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,491 units
- Official record key
device-enforcement:Z-1797-2015
Official wording
Reason: Nonapproved labeling claims (Sterile)
Code information: ALL Lots - 11406, 11414, 12439, 12466, and 02521.
Distribution pattern: Worldwide Distribution -- US, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WY and Hawaii; and, the countries of Canada and Bahrain.
Derived failure modes
-
Unknown
Nonapproved labeling claims (Sterile)