High FDA (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
Affected units: 15

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.

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High
Hanger-Bar 2P Medical Device Recalled for Loosening Set Screw
FDA (Devices) · 2022-04-06

Same hazard · fall hazard