Device product
Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.
Z-2249-2016
Product summary
- Event
- Event 74249
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,993 Units
- Official record key
device-enforcement:Z-2249-2016
Official wording
Reason: Product did not meet specifications for Zinc Acetate (OOS).
Code information: Lot # 668
Distribution pattern: 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.
Derived failure modes
-
Unknown
Product did not meet specifications for Zinc Acetate (OOS).