{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "113571", "product_res_number": "Z-0158-2013", "event_date_initiated": "2012-09-14", "event_date_posted": "2012-10-25", "recall_status": "Terminated", "event_date_terminated": "2013-04-23", "res_event_number": "63361", "product_code": "DTL", "k_numbers": [ "K833322" ], "product_description": "Gish 3/8 x 1/2\" Reducer Connector with Luer fitting, Item Numbers: EC2180S, Lot Numbers: 1108900099, 1119900091, 1203700129, 1208600013, 1219200107, Exp. Dates: 3/31/14, 7/31/14, 2/28/15, 3/31/15, 7/31/15.\n\nProduct Usage: The connectors are indicated for use in connecting flexible tubing used in extracorporeal blood or fluid circuits. The connectors are distributed as sterile stand alones and bulk non-sterile.", "code_info": "Item Numbers: EC2180S, Lot Numbers: 1108900099, 1119900091, 1203700129, 1208600013, 1219200107, Exp. Dates: 3/31/14, 7/31/14, 2/28/15, 3/31/15, 7/31/15.", "firm_fei_number": "1718850", "recalling_firm": "Sorin Group USA, Inc.", "address_1": "14401 W 65th Way", "city": "Arvada", "state": "CO", "postal_code": "80004", "additional_info_contact": "Jack Ellison\n303-467-6306", "reason_for_recall": "Due to a molding irregularity, certain lots of connectors have the potential to leak fluid or entrain air at the interface of the luer fitting and mating cap. Entrained air could result in patient injury.", "root_cause_description": "Process control", "action": "Sorin Group USA, Inc. sent a Product Recall letter to all affected customers by certified mail on September 14, 2012. The letter identified the affected products, problem and actions to be taken. Customers were instructed to discontinue use of the affected product, return all unused product to the firm and to complete and return a Response Form via fax or email. For further questions, contact the firm at 1-800-650-2623.", "product_quantity": "1,380 units", "distribution_pattern": "US Nationwide Distribution in the states of: AL, AR, CA, CO, CT, FL, IL, MI, MN, MO, MS, NC, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA and WI.", "openfda": { "k_number": [ "K790564", "K922840", "K854261", "K833322", "K915301", "K782095", "K912709", "K972654", "K092711", "K790804", "K854397", "K820864", "K831261", "K900652", "K863177", "K912969", "K802544", "K140475", "K790563", "K880831", "K860291", "K882717", "K840603", "K801200", "K853950", "K832625", "K022918", "K760843", "K911884", "K122811", "K113148", "K801399", "K091634", "K812407", "K812408", "K873488", "K052459", "K945931", "K897196", "K030077", "K961181", "K060759", "K073260", "K772299", "K884408", "K122301", "K791914", "K780056", "K840797", "K897137", "K914987", "K801404", "K870325", "K003604", "K792113", "K853099", "K993057", "K801402", "K052381", "K910845", "K813141", "K072556", "K892368", "K131124", 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