Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner cartons in one master carton;1 inner carton c
FDA device recall Z-2714-2016 · posted 2016-09-02 · Terminated
Recall details
- Recalling firm
- Best Sanitizers Inc
- Reason for recall
- Certain lots of the acid solution in Acecide-C are degrading faster than normal.
- Action taken
- Customer letters dated 8/2/16 will be sent.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MED
- Quantity affected
- 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
- Date initiated
- 2016-08-02
- Date posted
- 2016-09-02
- Date terminated
- 2017-08-18
- Location
- Walton, KY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACECIDE-C HIGH LEVEL DISINFECTANT AND STERILANT (K091210) | Best Sanitizers, Inc. | 2010-02-05 |