Recall Z-1797-2015— Amerx Health Care Corp.

Name: FDA recall Z-1797-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-25

Class II · Terminated

Class II FDA medical device recall by Amerx Health Care Corp., initiated 2015-02-25, terminated 2016-10-03. It names 2 FDA 510(k) clearances: K971918, K970133. Product: Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.. Reason: Nonapproved labeling claims (Sterile).

Recalling firm: Amerx Health Care Corp.
Classification: Class II
Status: Terminated
Initiated: 2015-02-25
Terminated: 2016-10-03
Firm location: Clearwater, FL, United States

510(k) clearances named in this recall

2 on FDA's record

K971918 — AMERIGEL OINTMENT SATURATED WOUND DRESSINGAmerx Health Care Corp.·cleared 1997-08-12
K970133 — AMERIGEL OINTMENTAmerx Health Care Corp.·cleared 1997-04-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Nonapproved labeling claims (Sterile)

Data sourced from openFDA. This site is unofficial and independent of the FDA.