CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks
FDA device recall Z-1940-2016 · posted 2016-06-09 · Terminated
Recall details
- Recalling firm
- Alcon Research, Ltd.
- Reason for recall
- Alcon is conducting this Voluntary Medical Device Removal for specific lots of its CENTURION FMS packs due to the possible presence of a molding irregularity found within the aspiration luer which may result in a reduction of vacuum within the aspiration line.
- Action taken
- The affected consignees were sent a recall notification letter on 4/28/16.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HQC
- Quantity affected
- 156,712 units
- Distribution
- US, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colunbia, Croatia, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hong Kong, Hungary, India, Ir
- Date initiated
- 2016-04-28
- Date posted
- 2016-06-09
- Date terminated
- 2017-03-31
- Location
- Fort Worth, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CENTURION VISION SYSTEM (K121555) | Alcon Laboratories, Inc. | 2012-12-21 |