Z-2640-2014Class II

Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads...

Name: Z-2640-2014 Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads...
Creator: Amerx Health Care Corp.
Published: 2014-07-11
License: https://open.fda.gov/license/

Amerx Health Care Corp. / initiated 2014-07-11 / Terminated / root cause: labeling and UDI

FDA source

Amerx Health Care Corp. began a recall of Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages CAT # A2002. Wound... on 2014-07-11. FDA classified it as Class II and gives the reason as "Not approved labeling claims (antimicrobial and autolytic debridement)". 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-2640-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-11
Posted: 2014-09-12
Terminated: 2015-07-22
Recalling firm: Amerx Health Care Corp.
Product: Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages CAT # A2002. Wound management.
Product code: MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Reason for recall: Not approved labeling claims (antimicrobial and autolytic debridement)
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: On July 21, 2014, Amerx Health Care Corporation telephoned all affected customers advising them of the recalled products. During the call the customers were instructed to: 1) Discontinue dispensing the lot(s) and promptly return via parcel post to the Clearwater facility. 2) If you dispose of the product on your own, provide proof of disposal. 3) You will be reimbursed by check or credit memo for returned or disposed goods and postage.
Quantity in commerce: 116,633 units
Distribution: Worldwide Distribution-USA (nationwide) including the District of Columbia, Virgin Islands, Puerto Rico, and Guam, and the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, 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, and WV, and the countries of Canada, England, Africa, and Australia.
Product codes and lots: Lot codes: JCA0086 through JCA0106.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2640-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2638-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-24	2014-09-12
Z-2639-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-24	2014-09-12
Z-2640-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-24	2014-09-12
Z-2641-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-24	2014-09-12

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)