Recall Z-2641-2014— Amerx Health Care Corp.

Name: FDA recall Z-2641-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-11

Class II · Terminated

Class II FDA medical device recall by Amerx Health Care Corp., initiated 2014-07-11, terminated 2015-07-22. It names one FDA 510(k) clearance: K971918. Product: Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management.. Reason: Not approved labeling claims (antimicrobial and autolytic debridement).

Recalling firm: Amerx Health Care Corp.
Classification: Class II
Status: Terminated
Initiated: 2014-07-11
Terminated: 2015-07-22
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 Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management.

Reason for recall

Not approved labeling claims (antimicrobial and autolytic debridement)

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