Z-0852-2022Class II

Hanger-Bar 2P 45cm

Name: Z-0852-2022 Hanger-Bar 2P 45cm
Creator: Human Care USA, Inc.
Published: 2021-11-01
License: https://open.fda.gov/license/

Human Care USA, Inc. / initiated 2021-11-01 / Open, Classified / root cause: manufacturing process

FDA source

Human Care USA, Inc. began a recall of Hanger-Bar 2P 45cm on 2021-11-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0852-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-11-01
Posted: 2022-03-31
Recalling firm: Human Care USA, Inc.
Product: Hanger-Bar 2P 45cm
Product code: FSA Lift, Patient, Non-Ac-Powered
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 11/01/2021, the firm emailed an "URGENT PRODUCT CORRECTION" Notification to customers/distributors informing them that Loctite may be missing on the stop-screw which holds the hanger-bar hook in place. This is the hook which connects to the distance strap. Because there is a possibility of the screw coming loose from the hook in that case the user may fall. If the user falls there is a risk of minor to more serious injury. This depends on the fall level, the surface user falls on and the strength and state of health of the user. Customers are instructed to: 1. Unscrew the M4 screw (fig. 1) and check the guide threads (see yellow arrow in fig. 2) and that Loctite has been applied to the M4 screw. If the M4 screw is missing or the threads are of poor quality (worn or damaged), the product should not be used. Contact the Recalling Firm. 2. Apply Loctite 243 (fig. 3) on the M4 screw (fig. 4). 3. Screw on the M4 screw again with a torque of 1.5 Nm (fig. 5) until it stops. Wait a few minutes until Loctite has dried. Then check that the hook can be swung freely (fig. 6). 4. The Recalling Firm requests that all customers confirm that they have received the Recall Notice and that the necessary action has been taken. A response form was sent along with Recall Notice. Send completed response forms to [email protected] For any questions, call - 512-476-7199 ext. 290
Quantity in commerce: 15 devices
Distribution: U.S. Nationwide distribution in the states of CA, IL, LA, MA, NV, OH, OK, PA, TX, UT, VA, and WV.
Product codes and lots: Part Number 72755 UPC Code: 881608800403 EAN Code: 7331599999714 Lot Number: 33164504

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0852-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0851-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-06	2022-03-31
Z-0852-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-06	2022-03-31

Product code FSA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)