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Stryker Medical Division of Stryker Corporation recalls Naera Hospital Bassinet, Model No. 4402

Recalled February 13, 2019 · FDA recall Z-0813-2019 · Stryker Medical Division of Stryker

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. · FDA Class II
Units
5915
Sold at
Nationwide distribution. Foreign distribution to Argentina, Australia, Canada, Chile, China, Colombia, Germany, India, Japan, Netherlands, South Africa, Turkey, Saudi Arabia, United Kingdom, and Mexico.

Description

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.

Product
Naera Hospital Bassinet, Model No. 4402
Manufacturer(s)
Stryker Medical Division of Stryker Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

Stryker Medical Division of Stryker Corporation recalls Naera Hospital Bassinet, Model No. 4402 | RecallWatchUSA