{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "171784", "product_res_number": "Z-0194-2020", "event_date_initiated": "2019-04-12", "event_date_created": "2019-10-25", "recall_status": "Terminated", "event_date_terminated": "2020-07-22", "res_event_number": "82534", "product_code": "FMQ", "product_description": "Posey Connected Twice-As-Tough Cuffs", "code_info": "Model # 2796 with Lots #'s : 7109T007, 7112T001, 122T083, 7185T008, 7192T034, 7194T051, 7200T090, 7250T051, 7263T007, 7313T054, 7355T062, 7361T073, 8018T059, 8038T045, 8041T035, 8081T066, 8122T001, 8122T088, 8129T006, 8130T065, 8344T055, 8347T174, 8346T075, 9002T023, 9064T123, and 9064T124. Model # 2797 with Lots #'s : 7038T010, 7044T051, 059T038, 7061T050, 7088T028, 7089T002, 7090T054, 7100T047, 7103T054, 7114T090, 7114T091, 7151T004, 7154T006, 7156T124, 7163T046, 7165T087, 7178T035, 7181T003, 7185T014, 7186T103, 7271T210, 7284T006, 7284T105, 7291T094, 7317T014, 7340T102, 7347T110, 7354T115, 8004T054, 8024T013, 8025T071, 8047T033, 8055T001, 8071T003, 8096T004, 8106T002, 8113T040, 8115T078, 8117T039, 8178T135, 8183T060, 8249T077, 8261T064, 8263T079, 8270T075, 8278T008, 8281T061, 8284T083, 8304T004, 8305T073, 8312T067, 8320T069, 8330T023, 8331T122, 9007T056, 9008T030, 9015T047, 9017T073, 9063T004, 9064T121, and 9064T122.", "firm_fei_number": "3014634341", "recalling_firm": "TIDI PRODUCTS", "address_1": "272 E Deerpath", "city": "Lake Forest", "state": "IL", "postal_code": "60045-5314", "additional_info_contact": "Customer Service\n800-447-6739", "reason_for_recall": "Not meeting design specifications.", "root_cause_description": "Process control", "action": "On April 5th the firm sent letters to their customers stating the following: Next Steps:\n1. Ensure that all caregivers and users of the Posey Connected Twice-As-Tough (TAT) Cuffs (nos. 2796 and 2797) are made aware of this Recall Notice.\n2. Refer to the enclosed TAT Cuff Lot Number List (Attachment 1) and check your inventory to determine if your facility has any affected units.\n3. Destroy affected TAT Cuff(s) by following the enclosed TAT Cuff Destruction Instructions (Attachment 2). Dispose of damaged products per your facilitys policy for BIOHAZARDOUS material.\n4. Complete the enclosed Customer Response and Proof of Destruction Form and return this form to the TIDI Products Regulatory Department.\n5. Product Replacement Product shipment will resume on or around April 12, 2019. Replacement orders will be fulfilled as Customer Response and Proof of Destruction Forms are received. Note: If you have zero inventory of affected product, please enter 0 in the Quantity section and return form as required.\nDistribution of this Recall Notice:\nPlease distribute this Recall Notice to appropriate individuals within your organization and to any organization where the potentially affected devices were transferred or sold.\nPlease maintain awareness of this notice and resulting action for a minimum of two years to ensure\neffectiveness of this corrective action.\nIn cases where customers opt not to proceed with completion of the recall requirements described\nabove, TIDI Products cannot accept any responsibility for safety related issues or legal liabilities\ncaused by the failure to respond to this Recall Notice.\nWe regret any inconvenience that this Recall Notice may cause.\nNote: Adverse reactions or quality problems experienced with the use of this product may be\nreported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or\nby fax.\nAdditional Comment\nIf you have any further questions or require assistance completing the Cust", "product_quantity": "7692 (7615 USA and 77 OUS)", "distribution_pattern": "AK, AR, CA, CT, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MN, MO, MS, MT, NC, NH, NJ, NM, NY, PA, SC, TN, TX, UT, VA, VT, WI, and WV\nCANADA, FRANCE, and THE NETHERLANDS", "openfda": { "k_number": [ "K963467", "K963492", "K980640", "K963362", "K963494", "K962834", "K963370", "K963504", "K962831", "K771629", "K963360", "K771715", "K972446", "K963471", "K970273", "K971948", "K963449", "K963561", "K963489", "K971536", "K972046", "K970275", "K963393", "K971561", "K963419", "K963372", "K801272", "K963773", "K963468", "K963464", "K963547", "K982178", "K010818", "K013239", "K962810", "K792012", "K963404", "K963447", "K963526", "K970274", "K963559", "K963421", "K760618", "K963460", "K962429", "K962832", "K963491", "K963470", "K925924", "K962839", "K963199", "K790172", "K962963", "K963557", "K963556", "K963456", "K970272", "K080448", "K963527", "K963552", "K963442", "K963490", "K081264", "K963378", "K963473", "K963416", "K963108", "K963099", "K812473", "K963294", "K963485", "K962626", "K963448", "K962778", "K963469", "K963564", "K963569", "K963410", "K963463", "K771632", "K963237", "K790699", "K963138", "K963430", "K963466", "K963436", "K963387", "K991591", "K780232", "K963453", "K962964", "K110377", "K963478", "K963477", "K963399", "K963554", "K963906", "K963371", "K963528", "K963422", "K963454", "K963243", "K963431", "K010644", "K963457", "K771636", "K963452", "K963474", "K963563", "K963411", "K972123", "K771659", "K963476", "K963414", "K963409", "K771630", "K963041", "K771635", "K771634", "K963465", "K963437", "K971742", "K963439", "K963374", "K963413", "K850470", "K972338", "K963462", "K963060", "K963458", "K962327", "K963435", "K963450", "K963472" ], "device_name": "Restraint, Protective", "medical_specialty_description": "General Hospital", "regulation_number": "880.6760", "device_class": "1", "registration_number": [ "3017264244", "3014925393", "3010865220", "2320762", "1054241", "1929691", "3013035022", "3013424071", "3010699203", "1060680", "3003495693", "3005841027", "3015277818", "2921578", "3015173212", "3015058854", "3021135929", "3010453133", "1026765", "3014680784", "3010359088", "3013195449", "3045058049", "3006400320", "1720747", "3008381089", "1043572", "3042941605", "3004198457", "3023812384", "1422634", "9680215", "3032534", "1055236", "1054236", "3005831263", "3011706862", "3045857302", "2126660", "1054786", "3006619688", "3031582434", "3017299798", "1043214", "1058584", "3009273990", "3005082755", "3011715925", "3033858895", "3006089112", "3020188747", "3030446844", "2431497", "3042176500", "3006336810", "3017181414", "3004183518", "1835377", "2321033", "3031564213", "1417592", "1926174", "3008403546", "1422443", "3008381107", "3015397169", "1824619", "3014926389", "3008973893", "2011171", "3016674288", "3043051412", "8021894", "3004125670", "2182345", "2027062", "3003102481", "3010459874", "3006251250", "3013847349", "3010452421", "3013180212", "2182318", "3013856565", "3002754225", "3044150131", "9681385", "3004491626", "1526711", "3014301596", "1523530", "9611343", "3020460367", "1724810", "3004425765", "1053198", "1034876", "1043615", "3010363540", "1531186", "3014421917", "3010807315", "3011191255", "9616086", "9681527", "3015930683", "3016678045", "2518417", "3018783057", "3004605321", "3007774549", "3012205931", "3004519921", "3027592416", "3008797789" ], "fei_number": [ "3017264244", "3014925393", "3010865220", "1929691", "3013035022", "3013424071", "3010699203", "3003040625", "3003495693", "3005841027", "3015277818", "2921578", "3015173212", "3015058854", "3021135929", "3010453133", "1026765", "3002565916", "3002889431", "3010359088", "3013195449", "3000215650", "1825560", "3045058049", "3006400320", "1720747", "3008381089", "1043572", "3042941605", "3004198457", "3023812384", "1000219637", "3005831263", "3011706862", "3045857302", "3003105930", "2126660", "1000114163", "3006619688", "3031582434", "3017299798", "1043214", "1000112877", "1000112881", "1000143485", "3009273990", "1000112968", "3005082755", "3011715925", "3033858895", "3001084824", "3003399881", "3006089112", "3020188747", "3030446844", "3042176500", "3006336810", "3017181414", "3004183518", "3001751372", "1000514656", "3031564213", "1417592", "1926174", "3000214954", "3008403546", "3008381107", "3015397169", "1824619", "3014926389", "3008973893", "3006076154", "2011171", "3016674288", "3043051412", "3004125670", "2182345", "2027062", "3003102481", "3010459874", "3006251250", "3013847349", "3010452421", "3013180212", "2182318", "3013856565", "3002754225", "3044150131", "3004491626", "1526711", "3014301596", "1523530", "1000208624", "3020460367", "3004425765", "3004021352", "1053198", "1000284313", "3003057333", "3005846326", "1034876", "1043615", "3010363540", "3014421917", "3010807315", "3011191255", "3015930683", "3016678045", "2518417", "3018783057", "3004605321", "3007774549", "3012205931", "3027592416", "3008797789" ] } } ] }