Amerx Health Care Corp.: Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.

Recall number

Z-1797-2015

Recalling firm

Amerx Health Care Corp.

Product

Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.

Status

Terminated

Initiated

2015-02-25

Posted

2015-06-12

Terminated

2016-10-03

Reason

Nonapproved labeling claims (Sterile)

Root cause

Labeling False and Misleading

Action

On March 9, 2015 the firm contacted its customers via telephone. Within that conversation the firm asked its customers to examine their inventory to determine if they have any of the affected lot numbers on hand and notify the firm for an immediate product substitution, credit or refund. Customers were asked to discontinue dispensing any product on hand, and notify any customers that the product may have been further distributed to. The firm also asked that the response form be completed and returned. If no contact was made via telephone, the firm sent a certified letter asking the firm(s) to do the same actions as the phone request. If you have any questions please call 1-800-448-9599 or e-mail marketcorrection@amerxhc.com.

Quantity

6,491 units

Distribution

Worldwide Distribution -- US, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WY and Hawaii; and, the countries of Canada and Bahrain.

Lot, serial or model codes

ALL Lots - 11406, 11414, 12439, 12466, and 02521.

510(k) numbers

["K970133","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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