CLASS II Device recall · Reported 10 Dec 2014 · FDA Enforcement Report

Amerigel Daily Dressing Packets Wound management recalled

Amerx Health Care is recalling Amerigel Daily Dressing Packets Wound management, distributed nationwide in the US. The recall was initiated on 26 Sep 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel # A2003, Lot #s: 2WD07

Quantity recalled1740

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0499-2015
FDA event ID: 69394
Recalling firm: Amerx Health Care, Clearwater, FL
Classification: Class II
Status: Terminated
Recall initiated: 26 Sep 2014
FDA classified: 3 Dec 2014
Reported: 10 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Processing Deviation
Device type: Other Medical Devices

Timeline

26 Sep 2014	Recall initiated by company
3 Dec 2014	Classified by FDA	+68 days
10 Dec 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Formulation deviation

The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.

Product as listed by the FDA

Amerigel Daily Dressing Packets Wound management

Where it was distributed

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.

Nationwide Alaska Alabama Arizona California Colorado Connecticut District of Columbia Florida Georgia Hawaii Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan

Questions about this recall

Why was it recalled?

Formulation deviation

Which lots are affected?

Model # A2003, Lot #s: 2WD07

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 69394

This product is part of a recall event; the main page for the event is Amerigel Saturated Gauze Dressing Wound management recalled.

Reported	Class	Recall	Company	Reason	Where
10 Dec 2014	CLASS II	Amerigel Saturated Gauze Dressing Wound management recalled	Amerx Health Care	Processing Deviation	Nationwide
10 Dec 2014	CLASS II	Amerigel Post-op Surgical Kits Wound management recalled	Amerx Health Care	Processing Deviation	Nationwide
10 Dec 2014	CLASS II	Amerigel Hydrogel Wound Dressing Wound management recalled	Amerx Health Care	Processing Deviation	Nationwide

More recalls from Amerx Health Care

All 10

Reported	Class	Recall	Company	Reason	Where
27 Jul 2016Device	CLASS II	Amerigel Hydrogel Wound Dressing Advanced Formula recalled	Amerx Health Care	Potency & Assay	26 states
24 Jun 2015Device	CLASS II	Amerigel Hydrogel Gauze Dressing , A5002 recalled by Amerx Health Care	Amerx Health Care	Sterility	45 states
10 Dec 2014Device	CLASS II	Amerigel Hydrogel Wound Dressing Wound management recalled	Amerx Health Care	Processing Deviation	Nationwide
10 Dec 2014Device	CLASS II	Amerigel Post-op Surgical Kits Wound management recalled	Amerx Health Care	Processing Deviation	Nationwide
10 Dec 2014Device	CLASS II	Amerigel Saturated Gauze Dressing Wound management recalled	Amerx Health Care	Processing Deviation	Nationwide

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