Z-1993-2014Class II

Amerigel Wound Dressing 55 gallons/drum

Name: Z-1993-2014 Amerigel Wound Dressing 55 gallons/drum
Creator: Kova Laboratories, Inc.
Published: 2014-03-21
License: https://open.fda.gov/license/

Kova Laboratories, Inc. / initiated 2014-03-21 / Terminated / root cause: manufacturing process

FDA source

Kova Laboratories, Inc. began a recall of Amerigel Wound Dressing 55 gallons/drum on 2014-03-21. FDA classified it as Class II and gives the reason as "Product may not have been manufactured pursuant to a validated process protocol and CGMP". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1993-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-21
Posted: 2014-07-04
Terminated: 2016-09-12
Recalling firm: Kova Laboratories, Inc.
Product: Amerigel Wound Dressing 55 gallons/drum
Product code: MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Reason for recall: Product may not have been manufactured pursuant to a validated process protocol and CGMP.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Kova Laboratories contacted customers with an URGENT: Medical Device Recall message by phone and e-mail 3/21/2014 and 4/21/2014, of the affected products to be returned.
Quantity in commerce: 3 drums
Distribution: Distributed in the states of FL and NJ.
Product codes and lots: Lot #3WD05.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1993-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1992-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-04
Z-1993-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-04

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)