Medical device recalls Moderate risk

Hill-Rom, Inc. recalls Stretch Leveller Model Number: 3156200 - The combination of this products allows the user to easily adjust/control the…

Recall date
August 11, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2599-2021
FDA classification
Class II
Brand / firm
Hill-Rom, Inc.
Sold / distributed
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, DE, IL, ME, MI, MO, MS, NJ, OH, PA, VA, WA and the countries of Argentina, Australia, Austria, Bolivia, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Gr…

Why it was recalled

Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall out of the Oct lift sheet back onto the surface it is being lifted from.

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

What was recalled

Stretch Leveller Model Number: 3156200 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.

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