Z-2638-2014 Class II Terminated
FDA device recall Z-2638-2014 was initiated by Amerx Health Care Corp. on July 11, 2014 and is designated Class II. Reason for recall: Not approved labeling claims (antimicrobial and autolytic debridement) The recall status is terminated (terminated July 22, 2015). Affected quantity: 382,620 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 24, 2014
- Initiation Date
- July 11, 2014
- Termination Date
- July 22, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 382,620 units
Product Description
Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management.
Reason for Recall
Not approved labeling claims (antimicrobial and autolytic debridement)
Distribution Pattern
Worldwide Distribution-USA (nationwide) including the District of Columbia, Virgin Islands, Puerto Rico, and Guam, and the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, 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, and WV, and the countries of Canada, England, Africa, and Australia.
Code Information
Lot codes: 3WD02, 3WD03, 3WD04, and 3WD05