{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "191797", "product_res_number": "Z-0851-2022", "event_date_initiated": "2021-11-01", "event_date_created": "2022-03-31", "recall_status": "Open, Classified", "res_event_number": "89509", "product_code": "FSA", "product_description": "Hanger-Bar 2P 45cm", "code_info": "Part Number 72754\nUPC Code: 881608800397\nEAN Code: 7331599999707\nLot Number: 33218501", "firm_fei_number": "3002833166", "recalling_firm": "Human Care USA, Inc.", "address_1": "4210 S Industrial Dr Ste 160 4210 S Industrial Dr", "address_2": "Ste 160", "city": "Austin", "state": "TX", "postal_code": "78744-1077", "additional_info_contact": "Customer Service\n512-476-7199", "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_description": "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.\n\nCustomers are instructed to:\n1. 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.\nIf 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.\n2. Apply Loctite 243 (fig. 3) on the M4 screw (fig. 4).\n3. 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).\n4. 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\n\nFor any questions, call - 512-476-7199 ext. 290", "product_quantity": "10 devices", "distribution_pattern": "U.S. Nationwide distribution in the states of CA, IL, LA, MA, NV, OH, OK, PA, TX, UT, VA, and WV.", "openfda": { "k_number": [ "K840997", "K780684", "K841395", "K841398", "K811899", "K851844", "K930625", "K942807", "K823206", "K860837", "K844976", "K792601", "K902141" ], "registration_number": [ "3010010434", "3005260401", "3015772781", "3011245426", "3015286905", "3012392312", "3013524663", "3032368", "9615246", "3021599329", "3010398927", "3018050094", "3003878287", "3013528441", "3010113803", "3014146451", "1221921", "3036107705", "3033506545", "3007518069", "3018117722", "1832066", "3034520", "3005841027", "2182762", "3026309274", "3010605276", "3044470904", "3007539307", "3027643666", "3005748481", "3040280511", "3027517735", "3007710870", "3006554924", "3013675759", "3004615451", "3008856821", 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