Recall Z-0497-2015— Amerx Health Care Corp.

Name: FDA recall Z-0497-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-26

Class II · Terminated

Class II FDA medical device recall by Amerx Health Care Corp., initiated 2014-09-26, terminated 2016-10-03. It names one FDA 510(k) clearance: K971918. Product: Amerigel Hydrogel Wound Dressing Wound management. Reason: Formulation deviation.

Recalling firm: Amerx Health Care Corp.
Classification: Class II
Status: Terminated
Initiated: 2014-09-26
Terminated: 2016-10-03
Firm location: Clearwater, FL, United States

510(k) clearances named in this recall

1 on FDA's record

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

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 Wound Dressing Wound management

Reason for recall

Formulation deviation

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