{ "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": "130891", "product_res_number": "Z-0491-2015", "event_date_initiated": "2014-09-29", "event_date_posted": "2014-12-01", "recall_status": "Terminated", "event_date_terminated": "2015-05-27", "res_event_number": "69541", "product_code": "LFL", "k_numbers": [ "K081459" ], "product_description": "Integra Selector Kit\nSterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgical Aspirator system. One of the tubing lumen transmits irrigation fluid from the console to the handpiece of the system, and the other tubing lumen transmits aspirated fluid and tissue back to the system console. The aspirator is intended to be used to facilitate the removal of cellular and other unwanted soft tissue. The system provides selective tissue disintegration with simultaneous irrigation and aspiration. The system has been designed for use by surgeons in the areas of neurosurgery and gastroenterology including laparoscopic procedures. Its use in other procedures is regarded as experimental and is thus subjecto to appropriate local regulatory approval", "code_info": "Lot Numbers: 130849;1132912;1132913;1132914;1133101;1133102;1133103;1133104;1133105;1133495;1134005;1134006;1134007;1134120;1134121;1134122;1134124;1134126;1134128;1134130;1134131;1134132;1134133;1134620;1134621;1134669;1134670;1134671;1134671;1134694;1134695;1140357;1141561;1141562;1141645;1141754;1141563;1141564;1141647;1142352;1142353;1142409; & 1142410", "firm_fei_number": "3003418325", "recalling_firm": "Integra LifeSciences Corp.", "address_1": "311 Enterprise Dr", "city": "Plainsboro", "state": "NJ", "postal_code": "08536-3344", "additional_info_contact": "Mr. David E. Gronostajski, RAC\n609-275-0500", "reason_for_recall": "Some specific lots of Selector Tubing may potentially leak irrigation fluid during use if not placed on the Selector handpiece in a specific manner.", "root_cause_description": "Device Design", "action": "Integra sent an 'Urgent- Medical Device Correction' letters/acknowledgement forms dated 9/29/2014 by traceable courier service. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory for the affected product, complete the attached form. Complete the other information on the form and return the form by email or fax.\nCustomers with questions should contact Customer Service at 1-855-532-1723.", "product_quantity": "6,358 tubing kits", "distribution_pattern": "Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Australia, Bulgaria, Canada, Germany, Great Britain, Greece, Hungary, Indonesia, Israel, Italy, Japan, Mexico, Portugal, Spain, Sweden, Thailand, Turkey, and Wales.", "openfda": { "k_number": [ "K223770", "K990572", "K212750", "K981262", "K980099", "K983316", "K801623", "K893926", "K111741", "K050885", "K031710", "K971580", "K192963", "K210567", "K032066", "K002906", "K190180", "K070313", "K181367", "K233036", "K983199", "K060245", "K972114", "K983065", "K211838", "K241700", "K182809", "K970471", "K212301", "K230427", "K100597", "K200427", "K231117", "K191555", "K864983", "K051036", "K141674", "K090864", "K081459", "K153371", "K000095", "K993628", "K931902", "K031305", "K132612", "K012753", 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