{ "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": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "191947", "product_res_number": "Z-0783-2022", "event_date_initiated": "2022-01-14", "event_date_created": "2022-03-11", "recall_status": "Terminated", "event_date_terminated": "2024-11-07", "res_event_number": "89562", "product_code": "FSA", "product_description": "(1)Traverse Rail Carrier E-System, wide\t31017XX\t component to Liko overhead lift,\n(2)Traverse Rail Carrier\t31025XX\t component to Liko overhead lift. \nIntended for to make safe lifting of a patient possible.\n\nAffected Devices:\n3101704 TRAV RAIL CARR E-SYST STD \n3102514 TR CARRIER SLIM/RAISED, LR\n3101705 TRAV RAIL CARR ESYST WIDE\n3102517 TR CARR. NORMAL/LOWER. LR\n3102506 TR CARRIER WIDE/RAISED ML \n3102519 TR CARR. LOW.LR 30MM/PAIR\n3102511 TR CARRIER NORMAL, LR \n3102531 TRAVERSE RL CARRIER STD/RAISED\n3102512 TR CARRIER WIDE, LR \n3102532 TRAVERSE RL CARRIER WD/RAISED\n3102513 TR CARRIER SLIM, LR\n 3102562 TR CARRIER, PARALLEL/WIDE", "code_info": "Distributed between 04JAN2021 and 24MAR2021.\nP/N \tProduct name \n3130001 \tMultirall 200 \n3301030 \tLikoGuard L\n3301040 \tLikoGuard XL \n3121001 \tLikorall 200\n3122005 \tLikorall 242 ES natural\n3122005NA\tLikorall 242 ES natural\n3122006 \tLikorall 242 ES white\n3122006NA \tLikorall 242 ES white\n3122009 \tLikorall 242 S natural\n3122009NA \tLikorall 242 S natural\n3122010\tLikorall 242 S white\n3122010NA\tLikorall 242 S white\n3122007\tLikorall 242 ES R2R, natural\n3122007NA\tLikorall 242 ES R2R, natural\n3122008\tLikorall 242 ES R2R, white\n3122008NA\tLikorall 242 ES R2R, white\n3122011\tLikorall 242 S R2R, natural\n3122011NA\tLikorall 242 S R2R, natural\n3122012\tLikorall 242 S R2R, white\n3122012NA\tLikorall 242 S R2R, white\n3123001\tLikorall 243 ES, natural\n3123001NA\tLikorall 243 ES, natural\n3123002\tLikorall 243 ES, white\n3123002NA\tLikorall 243 ES, white\n3122501\tLikorall 250 ES, natural\n3122501NA\tLikorall 250 ES, natural\n3122502\tLikorall 250 ES, white\n3122502NA\tLikorall 250 ES, white\n3124050\tLikorall 250 S, IRC, natural", "firm_fei_number": "1824206", "recalling_firm": "Hill-Rom, Inc.", "address_1": "1069 State Road 46 E", "city": "Batesville", "state": "IN", "postal_code": "47006-7520", "additional_info_contact": "Lauren Russ \n224-300-9690", "reason_for_recall": "Traverse rail carriage delivered with non-conforming screws are too short to ensure appropriate installation. There is potential that the screws are unable to secure the traverse rail appropriately and\ncould loosen over time causing the rail system to fall, potentially causing injury to caregivers and/or patients", "root_cause_description": "Nonconforming Material/Component", "action": "HillRom issued Urgent Medical Device Correction letter(FA-2021-11-004-LUL-002) on the 14th of January via UPS Ground service. Letter states reason for recall, health risk and action to take:\n\nActions to be taken by Customer:\nPlease identify if you have the potentially affected product in your facility (See affected device listing above). Do not use your traverse carrier until inspected by a Hillrom Technician. Return the response form below within two weeks. Upon receipt of the response form, Hillrom will contact you to schedule a visit to inspect your carriers. Should incorrect, non-conforming screws be present, these will be exchanged by an approved Hillrom technician.\n\nAction to be taken by the Distributor:\nPlease share this Field Safety Notice with your end users and complete the attached response\nform and return to hillromLUL002@sedgwick.com within two weeks. Hillrom will provide\nreplacement screws for Distributors to facilitate exchange among your end users.\nAction to be taken by Hillrom:\nHillrom will arrange a site visit to inspect the potentially affected units. If short screws are\nidentified, they will be exchanged with those of correct length.\nContact reference person\nIf you have any questions regarding this safety notice, please contact Hillrom Technical Support at 800-445-3720 or technical.support@hillrom.com .", "product_quantity": "Traverse Rail Carrier E-System, wide\t31017XX\t5 Traverse Rail Carrier\t31025XX\t1798", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of AT, CA, CZ, DE, DK, ES, FI, \nFR, GB, HK, IE, IL, IT, JP, NL, NO, NZ, RU, SE, SG, SK.", "openfda": { "k_number": [ "K840997", "K902141", "K860837", "K930625", "K823206", "K792601", "K841395", "K942807", "K851844", "K811899", "K844976", "K841398", "K780684" ], "registration_number": [ "3005748481", "3010509576", "3017869684", "3003775119", "3008771621", "3008406502", "3012643605", "3034538639", "3010359088", "3004615451", "3007710870", "9615386", "3012392312", "3007420694", "3009491742", "3007682310", "3023859", "3015005470", 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"3004727093", "3003040625", "1000112968", "3021256830", "3013675759", "3005753836", "3002833166", "3013318446", "3016590299", "3027643666", "3002913923", "3005260401", "3013354832", "3008906627", "3010605276", "3008311431", "3005068474", "3004461389", "3026925581", "3005484027", "3004034546", "3007031002", "3004905643", "3004168774", "3007689746", "3018117722", "3013557562", "3021599329", "3011495193", "1000112877", "3012316249", "3005202231", "3010010434" ], "device_name": "Lift, Patient, Non-Ac-Powered", "medical_specialty_description": "General Hospital", "regulation_number": "880.5510", "device_class": "1" } } ] }