DATEX--OHMEDA, INC.: GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers: 1) 2082844-001-01040418; 2) 2082844-001-01046784; 3) 2082844-001-0105

Hazard

Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general scientific consensus is that sensory irritation of the eyes is the most sensitive endpoint with respect to exposure to airborne formaldehyde and is the adverse effect clinically experienced at the lowest concentration.

Details from the source

Reason for recall: Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general scientific consensus is that sensory irritation of the eyes is the most sensitive endpoint with respect to exposure to airborne formaldehyde and is the adverse effect clinically experienced at the lowest concentration. Distribution: worldwide Quantity: 769 units Lot/code info: 1) 2082844-001-01040418, UDI: (01)00840682116862(21)TABC70024(11)230203, (01)00840682116862(21)TABC70035(11)230207, (01)00840682116862(21)TABC70037(11)230207, (01)00840682116862(21)TABC70038(11)230207, (01)00840682116862(21)TABC70045(11)230208, (01)00840682116862(21)TABC70052(11)230209, (01)00840682116862(21)TABC70054(11)230209, (01)00840682116862(21)TABC70056(11)230209, (01)00840682116862(21)TABC70060(11)230209, (01)00840682116862(21)TABC70064(11)230210, (01)00840682116862(21)TABC70068(11)230210, (01)00840682116862(21)TABC70069(11)230210, (01)00840682116862(21)TABC70070(11)230210; 2) 2082844-001-01046784, UDI: (01)008406821168622(21)TAB23060007SA(11)230209, (01)008406821168622(21)TAB23060008SA(11)230209, (01)008406821168622(21)TAB23060009SA(11)230209, (01)008406821168622(21)TAB23060010SA(11)230209, (01)008406821168622(21)TAB23060011SA(11)230209, (01)008406821168622(21)TAB23060012SA(11)230209, (01)008406821168622(21)TAB23060013SA(11)230209, (01)008406821168622(21)TAB23060014SA(11)230209, (01)008406821168622(21)TAB23060015SA(11)230209; 3) 2082844-001-01052324, UDI: (01)00840682116862(21)TABC70169(11)230228; 4) 2082844-001-01052572, UDI: (01)00840682116862(21)TABC70101(11)230215, (01)00840682116862(21)TABC70119(11)230217, (01)00840682116862(21)TABC70130(11)230220, (01)00840682116862(21)TABC70136(11)230221, (01)00840682116862(21)TABC70138(11)230222, (01)00840682116862(21)TABC70171(11)230301, (01)00840682116862(21)TABC70180(11)230302, (01)00840682116862(21)TABC70196(11)230306, (0

UPC codes

00840682116862, 008406821168

Source

Official record: FDA (Device enforcement) ↗

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