GE Medical Systems, LLC: Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610-000, 1107-9612-000, 1107-9616-000, 1107-9617-000, 2066

Hazard

Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.

Details from the source

Reason for recall: Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. Distribution: US Nationwide. Global Distribution. Quantity: 1573 units Lot/code info: REF 1107-9601-000, GTIN 0084068211253; REF 1107-9602-000, GTIN 00840682112659; REF 1107-9603-000, GTIN 00840682112574; REF 1107-9604-000, GTIN 00840682112925; REF 1107-9610-000, GTIN 00840682112864; REF 1107-9612-000, GTIN 00840682113236; REF 1107-9616-000, GTIN 00840682113069; REF 1107-9617-000, GTIN 00840682112666; REF 2066835-001, GTIN 00840682112857; REF 2069767-001, GTIN 00840682112505; REF 2078800-001, GTIN 00840682112512; REF 2091008-001, GTIN 00840682112437; REF 2091009-001, GTIN 00840682112802; REF M1098876, GTIN 00840682112710; REF M1145610, GTIN 00840682112765; REF M1220023, GTIN 00840682112789; REF M1220854, GTIN 00840682112826; REF M1221495, GTIN 00840682115902; REF M1233992, GTIN 00840682112451; Serial Numbers: AESC31001 AESC31009 AESC32001 AESC32004 AESC32007 AESC29004 AESD02013 AESC11019 AESC11022 AESC13002 AESC13024 AESC24015 AESC25017 AESC28017 AESC22013 AESD15005 AESD15011 AESC13011 AESC23007 AESC25004 AESD31023 AESC13020 AESC16013 AESC17013 AESC20007 AESC22007 AESC22020 AESC23005 AESC23009 AESC23012 AESC29031 AESC11018 AESD15009 AESD15017 AESD16001 AESC50022 AESD08005 AESD10013 AESD10016 AESD11012 AESD11013 AESD12001 AESD12002 AESD12011 AESD20017 AESD22023 AESC30010 AESC42010 AESC42018 AESC43024 AESC43028 AESC44003 AESC44004 AESC44006 AESC44019 AESD31013 AESD31028 AESD01017 AESC46003 AESC47012 AESC48003 AESC48011 AESC11020 AESC23051 AESC13017 AESC30015 AESD15001 AESC24024 AESC10013 AESC21027 AESC45012 AESC48004 AESC50006 AESC50010 AESD07008 AESC30019 AESC3

UPC codes

0084068211253, 00840682112659, 00840682112574, 00840682112925, 00840682112864, 00840682113236, 00840682113069, 00840682112666, 00840682112857, 00840682112505, 00840682112512, 00840682112437, 00840682112802, 00840682112710, 00840682112765, 00840682112789, 00840682112826, 00840682115902, 00840682112451

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.