Recall Z-2714-2016— Best Sanitizers Inc

Name: FDA recall Z-2714-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-02

Class II · Terminated

Class II FDA medical device recall by Best Sanitizers Inc, initiated 2016-08-02, terminated 2017-08-18. It names one FDA 510(k) clearance: K091210. Product: Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner cartons in one master carton;1 inner carton consists of a set of two liquids (1 acid & 1 buffer) banded together.. Reason: Certain lots of the acid solution in Acecide-C are degrading faster than normal..

Recalling firm: Best Sanitizers Inc
Classification: Class II
Status: Terminated
Initiated: 2016-08-02
Terminated: 2017-08-18
Firm location: Walton, KY, United States

510(k) clearances named in this recall

1 on FDA's record

K091210 — ACECIDE-C HIGH LEVEL DISINFECTANT AND STERILANTBest Sanitizers, Inc.·cleared 2010-02-05

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

Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner cartons in one master carton;1 inner carton consists of a set of two liquids (1 acid & 1 buffer) banded together.

Reason for recall

Certain lots of the acid solution in Acecide-C are degrading faster than normal.

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