Recall Z-1940-2016— Alcon Research, Ltd.
Class II · Terminated
Class II FDA medical device recall by Alcon Research, Ltd., initiated 2016-04-28, terminated 2017-03-31. It names one FDA 510(k) clearance: K121555. Product: CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks. Reason: 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..
- Recalling firm
- Alcon Research, Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-04-28
- Terminated
- 2017-03-31
- Firm location
- Fort Worth, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.