FDA Device recall Z-1940-2016

CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks

FDA Device
Class II
terminated
Published 2016-06-15

On 2016-06-15 the FDA classified a Class II recall of CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks by Alcon Research, citing 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 aspi….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1940-2016
Classification	Class II
Status	terminated
Initiated	2016-04-28
Published	2016-06-15
Last updated	2026-09-13 11:54 UTC
Company	Alcon Research
Distribution	n/a

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.

Identifiers

code_info	Lot Numbers: 1785989H 1785990H 1786004H 1786005H 1786006H 1786007H 1791520H 1791521H 1791522H 1791523H 1791… Lot Numbers: 1785989H 1785990H 1786004H 1786005H 1786006H 1786007H 1791520H 1791521H 1791522H 1791523H 1791524H 1791525H 1791526H 1791527H 1791528H 1791529H 1791845H 1791846H 1793690H 1793706H 1793707H 1793709H 1793710H 1793711H 1793712H 1793713H 1793714H 1793715H 1793716H 1794101H 1794102H 1794103H 1794104H 1794105H 1794106H 1794107H 1794108H 1794153H 1794154H 1794155H 1794156H 1794157H 1794158H 1794159H 1794160H 1794161H 1794162H 1794163H 1794164H 1794165H 1794166H 1794167H 1794168H 1794544H 1794545H 1794546H 1794547H 1794548H 1794549H 1794550H 1794551H 1794552H 1794553H 1794554H 1794555H 1794556H 1794557H 1794558H 1794559H 1794560H 1794561H 1794562H 1794563H 1794564H 1794565H 1822927H 1822928H 1822929H 1794169H 1794175H 1794176H 1794566H 1794567H 1794568H 1794569H 1794570H 1794571H 1794572H 1796505H 1796506H 1799220H 1799221H 1799222H 1799223H 1799224H 1799225H 1799226H 1799227H 17992

code_info

Lot Numbers: 1785989H 1785990H 1786004H 1786005H 1786006H 1786007H 1791520H 1791521H 1791522H 1791523H 1791…

Lot Numbers: 1785989H 1785990H 1786004H 1786005H 1786006H 1786007H 1791520H 1791521H 1791522H 1791523H 1791524H 1791525H 1791526H 1791527H 1791528H 1791529H 1791845H 1791846H 1793690H 1793706H 1793707H 1793709H 1793710H 1793711H 1793712H 1793713H 1793714H 1793715H 1793716H 1794101H 1794102H 1794103H 1794104H 1794105H 1794106H 1794107H 1794108H 1794153H 1794154H 1794155H 1794156H 1794157H 1794158H 1794159H 1794160H 1794161H 1794162H 1794163H 1794164H 1794165H 1794166H 1794167H 1794168H 1794544H 1794545H 1794546H 1794547H 1794548H 1794549H 1794550H 1794551H 1794552H 1794553H 1794554H 1794555H 1794556H 1794557H 1794558H 1794559H 1794560H 1794561H 1794562H 1794563H 1794564H 1794565H 1822927H 1822928H 1822929H 1794169H 1794175H 1794176H 1794566H 1794567H 1794568H 1794569H 1794570H 1794571H 1794572H 1796505H 1796506H 1799220H 1799221H 1799222H 1799223H 1799224H 1799225H 1799226H 1799227H 17992

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1940-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.