High FDA (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.
Category: Medical Device
Hazard: fall-hazard
hardware-failure
Affected units: 10

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Human Care USA, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Human Care USA, Inc.

See all →

High
Hanger-Bar 2P 45cm Recalled for Fall Hazard from Loosened Set Screw
FDA (Devices) · 2022-04-06

Same hazard · fall hazard