Reported Jun 15, 2016 · Terminated
CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks
Alcon Research, Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alcon Research, Ltd. · 6201 South Fwy · Fort Worth, TX · 76134-2099
Is this the product you have?
- CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks
- Lot codes and dates
- Lot Numbers
258 of 258 codes
1785989H1785990H1786004H1786005H1786006H1786007H1791520H1791521H1791522H1791523H1791524H1791525H1791526H1791527H1791528H1791529H1791845H1791846H1793690H1793706H1793707H1793709H1793710H1793711H1793712H1793713H1793714H1793715H1793716H1794101H1794102H1794103H1794104H1794105H1794106H1794107H1794108H1794153H1794154H1794155H1794156H1794157H1794158H1794159H1794160H1794161H1794162H1794163H1794164H1794165H1794166H1794167H1794168H1794544H1794545H1794546H1794547H1794548H1794549H1794550H
- Lot Numbers
- Amount recalled
- 156,712 units
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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