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U.S. Department of Health and Human Services

Class 2 Device Recall AcecideC High Level Disinfectant & Sterilant

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  Class 2 Device Recall AcecideC High Level Disinfectant & Sterilant see related information
Date Initiated by Firm August 02, 2016
Date Posted September 02, 2016
Recall Status1 Terminated 3 on August 18, 2017
Recall Number Z-2714-2016
Recall Event ID 74862
510(K)Number K091210  
Product Classification Sterilant, medical devices - Product Code MED
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.
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
Recalling Firm/
Manufacturer		 Best Sanitizers Inc
154 Mullen Dr
Walton KY 41094-9606
For Additional Information Contact Ms. Cindi Linville
859-485-2293
Manufacturer Reason
for Recall		 Certain lots of the acid solution in Acecide-C are degrading faster than normal.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MED and Original Applicant = BEST SANITIZERS, INC.
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