Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.
This recall has been terminated (originally issued June 12, 2015).
- Company
- Amerx Health Care Corp.
- Recall Initiated
- February 25, 2015
- Posted
- June 12, 2015
- Terminated
- October 3, 2016
- Recall Number
- Z-1797-2015
- Quantity
- 6,491 units
- Firm Location
- Clearwater, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Nonapproved labeling claims (Sterile)
Distribution
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.
Lot / Code Info
ALL Lots - 11406, 11414, 12439, 12466, and 02521.
Root Cause
Labeling False and Misleading
Action Taken
On March 9, 2015 the firm contacted its customers via telephone. Within that conversation the firm asked its customers to examine their inventory to determine if they have any of the affected lot numbers on hand and notify the firm for an immediate product substitution, credit or refund. Customers were asked to discontinue dispensing any product on hand, and notify any customers that the product may have been further distributed to. The firm also asked that the response form be completed and returned. If no contact was made via telephone, the firm sent a certified letter asking the firm(s) to do the same actions as the phone request. If you have any questions please call 1-800-448-9599 or e-mail marketcorrection@amerxhc.com.