Z-1797-2015 Class II Terminated
FDA device recall Z-1797-2015 was initiated by Amerx Health Care Corp. on February 25, 2015 and is designated Class II. Reason for recall: Nonapproved labeling claims (Sterile) The recall status is terminated (terminated October 3, 2016). Affected quantity: 6,491 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 24, 2015
- Initiation Date
- February 25, 2015
- Termination Date
- October 3, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,491 units
Product Description
Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.
Reason for Recall
Nonapproved labeling claims (Sterile)
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.
Code Information
ALL Lots - 11406, 11414, 12439, 12466, and 02521.