{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "114801", "product_res_number": "Z-0534-2013", "event_date_initiated": "2012-11-05", "event_date_posted": "2012-12-17", "recall_status": "Terminated", "event_date_terminated": "2015-03-04", "res_event_number": "63808", "product_code": "LFL", "k_numbers": [ "K062544" ], "product_description": "Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. \n\nMajor components of the AR1000 Wound Therapy System include an ultrasonic generator, converter hand piece, done-shaped applicator tip (qurette), and a saline supply reservoir. \n\nProduct Usage:\nThe Arobella Medical AR1000 Wound Therapy System is interned for the selective dissection and fragmentation of tissue, wound debridement ( of acute and chronic wounds, burns, and diseased or necrotic tissue), and cleansing irrigation of the wound site for the removal of debris, exudates, fragments, and other matter.", "code_info": "0001 and 0002", "firm_fei_number": "3007225330", "recalling_firm": "Arobella Medical, LLC", "address_1": "5929 Baker Rd Ste 470 5929 Baker Rd", "address_2": "Ste 470", "city": "Minnetonka", "state": "MN", "postal_code": "55345-4770", "additional_info_contact": "952-345-6840", "reason_for_recall": "This recall has been initiated because the Arobella Medical 6mm Qurette Q07 Lot Numbers 0001 and 0002 can fracture during use and may release a fragment or fragments. The 6 mm Qurette is a component of the AR1000 Quostic Wound Therapy System.", "root_cause_description": "Nonconforming Material/Component", "action": "Arobella Medical sent an \" Urgent: Medical Device Recall\" letter dated November 2, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately examine their inventory, quarantine and return any product subject to the recall. If the affected product have been further distributed, customers were advised to notify their customers of the product recall. For questions call 952-288-2810.", "product_quantity": "99", "distribution_pattern": "Worldwide distribution - US (nationwide) and the states of AL, CA, ID, IN, IA, MI, MN, MS, NJ, NM, OH, PA. 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