GE Healthcare Infant Incubator Recall: Airborne Formaldehyde Off-Gassing

Plain-English summary

The GE Healthcare Giraffe Incubator Carestation CS1 (32 model variants) is subject to recall due to potential airborne formaldehyde exposure during initial use. A total of 224 units have been distributed worldwide.

Prior to current manufacturing practices, newly manufactured incubators could release higher levels of airborne formaldehyde during clinical use. These levels would rapidly decrease over approximately one week. The manufacturer notified affected customers in June 2023 to run incubators for one week to potentially off-gas any residual airborne formaldehyde.

Formaldehyde exposure can cause sensory irritation of the eyes, which is the most sensitive endpoint to formaldehyde exposure at the lowest exposure concentrations.

Affected customers should follow the manufacturer's guidance to run incubators for one week before clinical use to minimize formaldehyde off-gassing. For specific product details including serial numbers and lot codes, refer to the FDA recall notice.

The recalled product

Product

GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; 3) 2082844-002-01058424; 4) 2082844-002-01069017; 5) 2082844-002-01089666; 6) 2082844-002-01090474; 7) 2082844-002-01091269; 8) 208

Manufacturer

DATEX--OHMEDA, INC.

Category

Medical Device — Infant Incubator

Hazard

• formaldehyde-exposure
• eye-irritation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distribution scope not specified by the agency.

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