The Recall Desk
HighFDA (Devices)·Z-0851-2022·Announced 2022-04-06

Hanger-Bar 2P Medical Device Recalled for Loosening Set Screw

Human Care USA, Inc. is recalling the Hanger-Bar 2P 45cm due to a manufacturing defect allowing the set screw to loosen, 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 an FDA Class II medical device recall for a risk-of-harm product—a loosening structural component that could cause a fall. Although no injuries have been reported, the potential for serious harm from a fall justifies a High severity rating.

Plain-English summary

Human Care USA, Inc. is recalling the Hanger-Bar 2P 45cm. The recall affects 10 devices distributed nationwide in California, Illinois, Louisiana, Massachusetts, Nevada, Ohio, Oklahoma, Pennsylvania, Texas, Utah, Virginia, and West Virginia. The product carries Part Number 72754, UPC Code 881608800397, EAN Code 7331599999707, and Lot Number 33218501.

The device is being recalled due to a manufacturing defect in which Loctite adhesive was not properly applied to the set screw. This omission can cause the set screw to loosen, creating a potential fall hazard.

Consumers who have this device should cease using it and contact the recalling firm for further instructions regarding return or replacement.

The recalled product

Product
Hanger-Bar 2P 45cm
Manufacturer
Human Care USA, Inc.
Hazard
  • fall-hazard
  • hardware-failure

Distribution

Distributed nationwide across the United States.