{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "197434", "product_res_number": "Z-1037-2023", "event_date_initiated": "2022-12-05", "event_date_posted": "2023-01-30", "recall_status": "Open, Classified", "res_event_number": "91314", "product_code": "FRG", "k_numbers": [ "K153025" ], "product_description": "Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider", "code_info": "GTIN: 00859464007281\nLot Number: All Lot Numbers\nSerial Number: All Serial Numbers", "firm_fei_number": "3012421755", "recalling_firm": "Turbett Surgical, Inc.", "address_1": "668b Phillips Rd Ofc 1 668b Phillips Rd", "address_2": "Ofc 1", "city": "Victor", "state": "NY", "postal_code": "14564-9741", "additional_info_contact": "Same\n585-755-0133", "reason_for_recall": "Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.", "root_cause_description": "Device Design", "action": "***UPDATE***\nTurbett Surgical issued via E-mails Product Alert directly to the Hospital departments utilizing the device on 12-27-2022. Letter states reason for recall, health risk and action to take:\nActions to be taken by the Customer/User: \n\n1. Immediately discontinue the use of the specific devices exhibiting one or more failure(s) listed below. \n\"\tMissing side supports \n\"\tBroken or cracked side tab support\n\"\tBackwall weld separation\n\"\tSide weld separation\n\"\tCrack in the backwall seam\n\n2. Email (quality@turbettsurgical.com) with the following information.\n\"\tHospital name \n\"\tSerial number(s)\n\"\tType of failure that your container exhibited\n\n3. Turbett Surgical will contact you to organize pick up of the damaged unit and shipment of a replacement unit.\n\nIf your container does not exhibit any of these failures, please continue to monitor and inspect the condition of the container and follow the Instructions For Use (IFU) as you continue utilizing your container.\n4. If your container does not exhibit any of these failures, please email quality@turbettsurgical.com stating that your container(s) do not exhibit any of these failures. Please continue to monitor and inspect your devices prior to assembling for sterilization AS WELL AS after sterilization and cooling to ensure expected outcomes. Reminder to follow the Instructions For Use (IFU) as you continue utilizing your TS-1200 container.\nIf you have any questions about the content of this letter, please contact Mark Petras at quality@turbettsurgical.com.\n\n\n________________________________________________________________________\nTurbett Surgical issued Emails to the Hospital department on 12/7/2022. Sales representatives were notified on 12/5/22 to switch out the other container. Letter states reason for recall, health risk and action to take:\n1. Immediately verify that the specific serial numbered devices listed below, continues to operate without creating wet loads or the sterilization process is not compromised.", "product_quantity": "61 units", "distribution_pattern": "US Nationwide distribution in the states of CA, IA, IN, NC, NH, NY, OH, LA, SD, TX, VA, WI.", "openfda": { "k_number": [ "K823902", "K151445", "K932036", "K013003", "K183401", "K221379", "K960204", "K810918", "K141612", "K181174", "K152458", "K962605", "K822211", "K960206", "K162362", "K252823", "K040865", "K960210", "K802428", "K974638", "K823223", "K172749", "K842644", "K122507", "K883376", "K251177", "K181957", "K822931", "K180139", "K811242", "K093649", "K841123", "K113353", "K171533", "K192147", "K162162", "K041096", "K935683", "K141826", "K233777", "K990761", "K023658", "K062100", "K941467", "K760662", "K110867", "K182184", "K943090", "K062704", "K955678", "K780294", "K052665", "K953678", "K234132", "K951704", "K221016", "K770514", "K931202", "K760758", 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