Z-2249-2016Class II

Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz

Name: Z-2249-2016 Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz
Creator: Amerx Health Care Corp.
Published: 2016-05-20
License: https://open.fda.gov/license/

Amerx Health Care Corp. / initiated 2016-05-20 / Terminated

FDA source

Amerx Health Care Corp. began a recall of Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz on 2016-05-20. FDA classified it as Class II and gives the reason as "Product did not meet specifications for Zinc Acetate (OOS)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2249-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-20
Posted: 2016-07-20
Terminated: 2016-12-14
Recalling firm: Amerx Health Care Corp.
Product: Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.
Product code: KMJ Lubricant, Patient
Reason for recall: Product did not meet specifications for Zinc Acetate (OOS).
FDA root 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 [email protected].
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.
Product codes and lots: Lot # 668

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2249-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2249-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-20

Product code KMJ

K970133UnclassifiedAmerigel OintmentAmerx Health Care Corp. / cleared 1997-04-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)