Z-2714-2016Class II

Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner cartons in one master carton;1...

Name: Z-2714-2016 Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner cartons in one master carton;1...
Creator: Best Sanitizers Inc
Published: 2016-08-02
License: https://open.fda.gov/license/

Best Sanitizers, Inc. / initiated 2016-08-02 / Terminated / root cause: manufacturing process

FDA source

Best Sanitizers Inc began a recall of 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... on 2016-08-02. FDA classified it as Class II and gives the reason as "Certain lots of the acid solution in Acecide-C are degrading faster than normal". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2714-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-02
Posted: 2016-09-02
Terminated: 2017-08-18
Recalling firm: Best Sanitizers, Inc.
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.
Product code: MED Sterilant, Medical Devices
Reason for recall: Certain lots of the acid solution in Acecide-C are degrading faster than normal.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Customer letters dated 8/2/16 will be sent.
Quantity in commerce: 3,023 cases USA; 666 cases shipped to Canada (OTC drug there)
Distribution: Distributed to one (1) account in the state of PA. Distributed to one (1) account in Canada
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2714-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2714-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-02

Product code MED

K091210Class IIAcecide-C High Level Disinfectant and SterilantBest Sanitizers, Inc. / cleared 2010-02-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)