Recall Z-2249-2016— Amerx Health Care Corp.

Name: FDA recall Z-2249-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-20

Class II · Terminated

Class II FDA medical device recall by Amerx Health Care Corp., initiated 2016-05-20, terminated 2016-12-14. It names one FDA 510(k) clearance: K970133. Product: Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.. Reason: Product did not meet specifications for Zinc Acetate (OOS)..

Recalling firm: Amerx Health Care Corp.
Classification: Class II
Status: Terminated
Initiated: 2016-05-20
Terminated: 2016-12-14
Firm location: Clearwater, FL, United States

510(k) clearances named in this recall

1 on FDA's record

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 Wound Dressing Advanced Formula for wound management 1 oz.

Reason for recall

Product did not meet specifications for Zinc Acetate (OOS).

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