Amerx Health Care Corp.: Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. Wound management.

Recall number

Z-2639-2014

Recalling firm

Amerx Health Care Corp.

Product

Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. Wound management.

Status

Terminated

Initiated

2014-07-11

Posted

2014-09-12

Terminated

2015-07-22

Reason

Not approved labeling claims (antimicrobial and autolytic debridement)

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

21,108 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.

Lot, serial or model codes

Lot codes: 05368, 05345, 09282, 10295, 12201, 12303, 12303, 12328, 13100, 13115, and 13180.

510(k) numbers

["K971918"]

PMA numbers

not on file

Product code

MGQ

Firm FEI

1000525408

Firm city

Clearwater

Firm state

FL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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