Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.
FDA Recall Z-2249-2016 · Posted None
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Recalling FirmAmerx Health Care Corp.
Recall StatusTerminated
Product CodeKMJ
Date Initiated2016-05-20
Date Terminated2016-12-14
Product Quantity6,993 Units
Reason for Recall
Product did not meet specifications for Zinc Acetate (OOS).
Firm 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 [email protected].
Root Cause
Other
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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