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FDA Medical Device Recalls (openFDA)

Best Sanitizers Inc: 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.

Recall number
Z-2714-2016
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.
Status
Terminated
Initiated
2016-08-02
Posted
2016-09-02
Terminated
2017-08-18
Reason
Certain lots of the acid solution in Acecide-C are degrading faster than normal.
Root cause
Nonconforming Material/Component
Action
Customer letters dated 8/2/16 will be sent.
Quantity
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
Lot, serial or model codes
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
510(k) numbers
["K091210"]
PMA numbers
not on file
Product code
MED
Firm FEI
3005763425
Firm city
Walton
Firm state
KY
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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