Medical device recalls Moderate risk

Hanger-Bar 2P 45cm recalled over fall hazard

Recall date
November 1, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Human Care USA, Inc. recalls Hanger-Bar 2P 45cm
Recall number
Z-0851-2022
FDA classification
Class II
Brand / firm
Human Care USA, Inc.
Sold / distributed
U.S. Nationwide distribution in the states of CA, IL, LA, MA, NV, OH, OK, PA, TX, UT, VA, and WV.

Why it was recalled

The Hanger-Bar is being recalled due to the potential for the set screw loosening as a result of a manufacturing issue (failure to apply Loctite adhesive). As a result of the set screw loosening, there is the potential for a fall hazard.

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

What was recalled

Hanger-Bar 2P 45cm

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