Class 2 Device Recall HangerBar

• Date Initiated by Firm: November 01, 2021
• Create Date: March 31, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0852-2022
• Recall Event ID: 89509
• Product Classification: Lift, patient, non-ac-powered - Product Code FSA
• Product: Hanger-Bar 2P 45cm
• Code Information: Part Number 72755 UPC Code: 881608800403 EAN Code: 7331599999714 Lot Number: 33164504
• Recalling Firm/ Manufacturer: Human Care USA, Inc.; 4210 S Industrial Dr Ste 160; Austin TX 78744-1077
• For Additional Information Contact: Customer Service; 512-476-7199
• Manufacturer 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.
• FDA Determined 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 greg.anderson@humancaregroup.com 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.