Recall Z-1992-2014— Kova Laboratories, Inc.

Name: FDA recall Z-1992-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-21

Class II · Terminated

Class II FDA medical device recall by Kova Laboratories, Inc., initiated 2014-03-21, terminated 2016-09-12. It names one FDA 510(k) clearance: K971918. Product: Amerigel Wound Dressing 1 oz. tube. Reason: Product may not have been manufactured pursuant to a validated process protocol and CGMP..

Recalling firm: Kova Laboratories, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-03-21
Terminated: 2016-09-12
Firm location: Margate, 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 Wound Dressing 1 oz. tube

Reason for recall

Product may not have been manufactured pursuant to a validated process protocol and CGMP.

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