Recall Z-2714-2016
Best Sanitizers Inc · initiated August 2, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / 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
Reason for recall
Certain lots of the acid solution in Acecide-C are degrading faster than normal.
FDA-determined cause: Nonconforming Material/Component
Action taken
Customer letters dated 8/2/16 will be sent.
Details
- Recall number
- Z-2714-2016
- Initiated
- August 2, 2016
- Posted by FDA
- September 2, 2016
- Terminated
- August 18, 2017
- Product code
- MED – Sterilant, Medical Devices
- 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
- Recalling firm
- Best Sanitizers Inc, Walton, KY