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Recall Observatory FDA recall evidence

Device 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.

Z-2714-2016

August 02, 2016

Class II

Product summary

Firm
Best Sanitizers Inc
Event
Event 74862
Status
Terminated
Classification
Class II
Quantity
3,023 cases USA; 666 cases shipped to Canada (OTC drug there)
Official record key
device-enforcement:Z-2714-2016

Official wording

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

Code information: 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

Distribution pattern: Distributed to one (1) account in the state of PA. Distributed to one (1) account in Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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