{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "170520", "product_res_number": "Z-1351-2019", "event_date_initiated": "2019-02-04", "event_date_created": "2019-05-16", "recall_status": "Open, Classified", "res_event_number": "81977", "product_code": "FSA", "product_description": "Molift 2-Point sling bar, an accessory for Molift Mover 205. Item nos. 1430016\n1430017\n1430021", "code_info": "All units manufactured between May 2013 and October 2018. Date of manufacture is labeled on the product.", "firm_fei_number": "3004137175", "recalling_firm": "Moller Vital", "address_1": "Hadelandsvegen 2 2 hadelandsvegen", "address_2": "P.o. Box 408", "city": "Gjovik", "country": "Norway", "reason_for_recall": "The firm has received 7 reports of malfunction for the device in which the hooks have broken off, potentially leading the sling to slip out of the sling bar and causing the patient to fall.", "root_cause_description": "Use error", "action": "On February 4, 2019, the firm notified customers of the recall via Urgent Field Safety Notice letter. The letter alerted customers to the recalled product.\n\nThe firm stated that all new 2-Point Sling Bars are now equipped with metal alloy hooks instead of the previously used composite hooks. As part of this recall, the firm will replace the recalled devices with the new design.\n\nDistributors were asked to do the following:\n\n1)\tRead the instructions, and complete and return the customer response form\n2)\tNotify affected customers of the recall\n3)\tReview the list of sales records from Etac Supply Gjvik and supply additional information from your records.\n4)\tIdentify and contact end-customers/users and decide the requirement for ordering new units\n5)\tOrder new 2-Point Sling Bars from Etac Supply Gjvik \n6)\tShip replacement units to end customers accompanied by replacement instructions (see user manual) and the Consignee Form. The End-User/Customer must perform the replacement and fill the replacement records (green fields) in the consignee form and return a signed copy to the distributor.\n7)\tReceive the signed Consignee Form from end-users/customers. Perform weekly reporting to Etac Supply Gjvik in the same spreadsheet that contains the sales records. The signed Consignee Forms must be returned to Etac Supply Gjvik as a complete package upon finalizing all replacements.", "product_quantity": "427 total", "distribution_pattern": "Domestic distribution to Arizona, Delaware, Florida, Georgia, Massachusetts, Ohio, South Carolina, Texas, Washington, and Wisconsin.\n\nForeign distribution to Canada, Asia, Europe, and Australia.", "openfda": { "k_number": [ "K844976", "K930625", "K841395", "K841398", "K792601", "K860837", "K902141", "K780684", "K811899", "K840997", "K851844", "K823206", "K942807" ], "registration_number": [ "3009265647", "3013528441", "3013557562", "2132280", "3008906627", "3009955851", "3009544661", "3039318471", "3005613467", "3034538639", "9616091", "3031027436", "3018229265", "3007710870", "3008856821", "3040280511", "3015286905", "3009157571", "9681684", "3003775119", "3042255028", "3006554924", "3008941254", "3013354832", "1041130", "3005755627", "1832066", "9615246", "3017375560", "3033506545", "1000406324", 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"3036801251", "3007048057", "3007420694", "3012292104", "3016678044", "3006662254", "1000153536", "3011495193", "3033790380", "3029906624", "3002833166", "3010509576", "3011497619", "3031233916", "3007005431", "3006291016", "3003878287", "1000164498", "3007238754", "3044744974" ], "device_name": "Lift, Patient, Non-Ac-Powered", "medical_specialty_description": "General Hospital", "regulation_number": "880.5510", "device_class": "1" } } ] }