Z-1797-2015Class II

Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management

Name: Z-1797-2015 Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management
Creator: Amerx Health Care Corp.
Published: 2015-02-25
License: https://open.fda.gov/license/

Amerx Health Care Corp. / initiated 2015-02-25 / Terminated / root cause: labeling and UDI

FDA source

Amerx Health Care Corp. began a recall of Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management on 2015-02-25. FDA classified it as Class II and gives the reason as "Nonapproved labeling claims (Sterile)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1797-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-25
Posted: 2015-06-12
Terminated: 2016-10-03
Recalling firm: Amerx Health Care Corp.
Product: Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.
Product code: MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Reason for recall: Nonapproved labeling claims (Sterile)
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: On March 9, 2015 the firm contacted its customers via telephone. Within that conversation the firm asked its customers to examine their inventory to determine if they have any of the affected lot numbers on hand and notify the firm for an immediate product substitution, credit or refund. Customers were asked to discontinue dispensing any product on hand, and notify any customers that the product may have been further distributed to. The firm also asked that the response form be completed and returned. If no contact was made via telephone, the firm sent a certified letter asking the firm(s) to do the same actions as the phone request. If you have any questions please call 1-800-448-9599 or e-mail [email protected].
Quantity in commerce: 6,491 units
Distribution: Worldwide Distribution -- US, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WY and Hawaii; and, the countries of Canada and Bahrain.
Product codes and lots: ALL Lots - 11406, 11414, 12439, 12466, and 02521.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1797-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1797-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-24	2015-06-12

Product code MGQ

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)