The agency recommends providers continue to use the neonatal incubators because they are “critical” for “infants less than four weeks old that cannot maintain their body temperature.” The FDA said it is investigating the potential risk, which could be coming from the materials used to make the products.
No adverse events, such as serious injury or death, have been reported to the FDA. The warning letter did not specify which models are under review.
Some of the chemicals possibly posing a risk include formaldehyde and cyclohexanone, which “may lead to problems such as neurological impairment or respiratory problems (such as asthma, decreased lung function, inflammation or irritation), which is concerning for neonates who may have immature pulmonary functions, and other comorbidities,” the FDA said.
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