The Recall Desk
HighFDA (Devices)·Z-0852-2022·Announced 2022-04-06

Hanger-Bar 2P 45cm Recalled for Fall Hazard from Loosened Set Screw

Human Care USA, Inc. is recalling the Hanger-Bar 2P 45cm because the set screw may loosen due to a manufacturing defect, creating a fall hazard.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall with a potential fall hazard from a manufacturing defect. The recall addresses a theoretical risk of falls without reported injuries, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Human Care USA, Inc. is recalling the Hanger-Bar 2P 45cm due to a manufacturing defect that fails to apply Loctite adhesive to the set screw. As a result, the set screw may loosen, creating a potential fall hazard.

Approximately 15 devices have been distributed nationwide in California, Illinois, Louisiana, Massachusetts, Nevada, Ohio, Oklahoma, Pennsylvania, Texas, Utah, Virginia, and West Virginia. The affected units can be identified by Part Number 72755, UPC Code 881608800403, EAN Code 7331599999714, and Lot Number 33164504.

Consumers who own the affected Hanger-Bar 2P 45cm should contact Human Care USA, Inc. for further information and instructions regarding the recall.

The recalled product

Product
Hanger-Bar 2P 45cm
Manufacturer
Human Care USA, Inc.
Category
Medical Device
Hazard
  • fall-hazard

Distribution

Distributed nationwide across the United States.

Related recalls

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