Recall Z-2640-2014 ยท MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Amerx Health Care Corp.
Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages CAT # A2002. Wound management.
| Date | Sep 12, 2014 (initiated Jul 11, 2014) |
| Status | Terminated |
| Reason | Not approved labeling claims (antimicrobial and autolytic debridement) |
| Root cause | Labeling design |
| Action | On July 21, 2014, Amerx Health Care Corporation telephoned all affected customers advising them of the recalled products. During the call the customers were instructed to: 1) Discontinue dispensing the lot(s) and promptly return via parcel post to the Clearwater facility. 2) If you dispose of the product on your own, provide proof of disposal. 3) You will be reimbursed by check or credit memo for returned or disposed goods and postage. |
| Quantity | 116,633 units |
| Distribution | 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, a |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971918 | AMERIGEL OINTMENT SATURATED WOUND DRESSING Amerx Health Care Corp., Aug 12, 1997 |