FDA-Device2019-02-13Class II

Naera Hospital Bassinet, Model No. 4402

Stryker Medical Division of Stryker Corporation
Hazard

It was identified that the volume of air inside the mattress may expand in regions of high altitude which may result in an unintended gap between the plateau of the inflated patient surface and tub. A Health Hazard Evaluation was completed which identified the potential risk of patients moving out of position and rolling over on the mattress. While the highest possible severity of harm associated with this condition is death, there have been no reports of injury or harm. This condition has only presented in regions of high altitude; however, Stryker has chosen to replace all Naera mattresses in the field.

Sold states
Nationwide distribution. Foreign distribution to Argentina, Australia, Canada, Chile, China, Colombia, Germany, India, Japan, Netherlands, South Africa, Turkey, Saudi Arabia, United Kingdom, and Mexico.
Affected count
5915
Manufactured in
3800 E Centre Ave, Portage, MI, United States
Products
Naera Hospital Bassinet, Model No. 4402

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0813-2019

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