Z-0500-2015Class II

Amerigel Saturated Gauze Dressing Wound management

Name: Z-0500-2015 Amerigel Saturated Gauze Dressing Wound management
Creator: Amerx Health Care Corp.
Published: 2014-09-26
License: https://open.fda.gov/license/

Amerx Health Care Corp. / initiated 2014-09-26 / Terminated

FDA source

Amerx Health Care Corp. began a recall of Amerigel Saturated Gauze Dressing Wound management on 2014-09-26. FDA classified it as Class II and gives the reason as "Formulation deviation". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0500-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-26
Posted: 2014-12-04
Terminated: 2016-10-03
Recalling firm: Amerx Health Care Corp.
Product: Amerigel Saturated Gauze Dressing Wound management
Product code: MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Reason for recall: Formulation deviation
FDA root cause: Mixed-up of materials/components
Action: Amerx Health Care Corporation sent an URGENT: DEVICE RECALL letter instructing consignees to examine their inventory and immediately determine if they have any of the Lot numbers on hand and to quarantine the product subject to recall. In addition, if they may have further distributed the product, please notify their customers and/or post the enclosed letter in a visible location for the customer to read. Customers with questions were instructed to call 800-448-9599 or email [email protected]. For questions regarding this recall call 727-443-0530.
Quantity in commerce: 21,108
Distribution: Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, WV, Virgin Islands, Puerto Rico, Guam, Hawaii and District of Columbia and Internationally to: Canada, England, Africa, and Australia.
Product codes and lots: Model # A5002, Lot #s: 05368, 05345, 09282, 10295, 12201, 12303, 12322, 12328, 13100, 13115, 13180

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0500-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0497-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-10	2014-12-03
Z-0498-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-10	2014-12-03
Z-0499-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-10	2014-12-03
Z-0500-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-10	2014-12-03

Product code MGQ

K971918UnclassifiedAmerigel Ointment Saturated Wound DressingAmerx Health Care Corp. / cleared 1997-08-12

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)