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