Events

Recall of AcecideC High Level Disinfectant & Sterilant

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Best Sanitizers Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74862
  • Event Risk Class
    Class 2
  • Event Number
    Z-2714-2016
  • Event Initiated Date
    2016-08-02
  • Event Date Posted
    2016-09-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148621
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Sterilant, medical devices - Product Code MED
  • Reason
    Certain lots of the acid solution in acecide-c are degrading faster than normal.
  • Action
    Customer letters dated 8/2/16 will be sent.

Device

AcecideC High Level Disinfectant & Sterilant
  • Model / Serial
    Lot Numbers: 16012ACE EXP 01/17,16036ACE EXP 02/17,  16015ACE EXP 01/17, 16040ACE EXP 02/17, 16019ACE EXP 01/17, 16043ACE EXP 02/17, 16022ACE EXP 01/17, 16048ACE EXP 02/17, 16026ACE EXP 01/17, 16050ACE EXP 02/17, 16033ACE EXP 02/17.  Lot Numbers 16015ACE EXP 01/17, 16036ACE EXP 02/17 were shipped to Olympus in Canada
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to one (1) account in the state of PA. Distributed to one (1) account in Canada
  • 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.
  • Manufacturer
    Best Sanitizers Inc

Manufacturer

Best Sanitizers Inc
  • Manufacturer Address
    Best Sanitizers Inc, 154 Mullen Dr, Walton KY 41094-9606
  • Manufacturer Parent Company (2017)
    Best Sanitizers Inc.
  • Source
    USFDA