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

Recall date

October 10, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0813-2019

FDA classification

Class II

Brand / firm

Stryker Medical Division of Stryker Corporation

Sold / distributed

Nationwide distribution. Foreign distribution to Argentina, Australia, Canada, Chile, China, Colombia, Germany, India, Japan, Netherlands, South Africa, Turkey, Saudi Arabia, United Kingdom, and Mexico.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Naera Hospital Bassinet, Model No. 4402