Recall Z-2714-2016 ยท MED Sterilant, Medical Devices
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.
| Date | Sep 2, 2016 (initiated Aug 2, 2016) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091210 | ACECIDE-C HIGH LEVEL DISINFECTANT AND STERILANT Best Sanitizers, Inc., Feb 5, 2010 |