Recall Z-0498-2015— Amerx Health Care Corp.

Name: FDA recall Z-0498-2015
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 Post-op Surgical Kits 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 Post-op Surgical Kits Wound management

Reason for recall

Formulation deviation

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