Recall Z-2249-2016
Amerx Health Care Corp. · initiated May 20, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.
Codes / lots: Lot # 668
Reason for recall
Product did not meet specifications for Zinc Acetate (OOS).
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-2249-2016
- Initiated
- May 20, 2016
- Terminated
- December 14, 2016
- Product code
- KMJ – Lubricant, Patient
- Quantity
- 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.
- Recalling firm
- Amerx Health Care Corp., Clearwater, FL