Class 2 Device Recall Amerigel Hydrogel Wound Dressing

• Date Initiated by Firm: May 20, 2016
• Create Date: July 20, 2016
• Recall Status: Terminated on December 14, 2016
• Recall Number: Z-2249-2016
• Recall Event ID: 74249
• 510(K)Number: K970133
• Product Classification: Lubricant, patient - Product Code KMJ
• Product: Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.
• Code Information: Lot # 668
• Recalling Firm/ Manufacturer: Amerx Health Care Corp.; 1300 S Highland Ave; Clearwater FL 33756-6519
• For Additional Information Contact: James Anderson; 727-443-0530
• Manufacturer Reason for Recall: Product did not meet specifications for Zinc Acetate (OOS).
• FDA Determined Cause: Other
• Action: Initial recall notification was sent to distributors, informing them of the voluntary recall and providing instructions on expanding the recall to the wholesale level. Distributors were instructed to identify recalled product in their inventory, quarantine any recalled product, and to complete and fax back a Recall Response Form. Contact information was provided for those with questions: 1-800-448-9599 and recall@amerxhc.com.
• Quantity in Commerce: 6,993 Units
• Distribution: AR, AZ, CA, CO, CT, FL, GA, IL, IN, MA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, & Alaska. Bahrain & Colombia.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KMJ and Original Applicant = AMERX HEALTH CARE CORP.