{ "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": "211437", "product_res_number": "Z-0819-2025", "event_date_initiated": "2024-11-26", "event_date_posted": "2025-01-07", "recall_status": "Completed", "res_event_number": "95881", "product_code": "PIF", "k_numbers": [ "K142989" ], "product_description": "AMT Mini Enteral Extension Set, 12\" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222", "code_info": "Lot Code: Model No: E6-1222\nUDI-DI: (01)00842071107086(17)270401(10)240424-628\nLot number: 240424-628\nExp. Date: 2027-04-01", "firm_fei_number": "1526012", "recalling_firm": "Applied Medical Technology Inc", "address_1": "8006 Katherine Blvd", "city": "Brecksville", "state": "OH", "postal_code": "44141-4202", "additional_info_contact": "Dan Filler\n440-7174000", "reason_for_recall": "The extension sets subject to this recall have ENFit connections, although they should have non- ENFit connections. ENFit connectors will only fit with other ENFit-compatible devices, and will not fit with non-ENFit connectors.", "root_cause_description": "Under Investigation by firm", "action": "An \"URGENT: MEDICAL DEVICE RECALL\" notification letter dated 11/26/24 was sent to customers.\n\nACTIONS TO BE TAKEN:\nCUSTOMER OR USER:\nApplied Medical Technology, Inc. requests that customers IMMEDIATELY TAKE THE FOLLOWING ACTIONS:\n\" Examine your inventory and isolate/quarantine pending return of the product subject to this recall.\n\" Do not use any device subject to this recall.\n\" Complete and return to Applied Medical Technology, Inc. the enclosed RECALL NOTIFICATION ACKNOWLEDGMENT via fax or send by mail.\n\" Please contact Applied Medical Technology, Inc. either by phone at 440-717-4000, or via email at cs@appliedmedical.net, to make arrangements for the return of any devices related to this recall. Include the product, all of its components, and any available packaging and labeling associated with the device. An RMA number will only be issued for pouches with lot number 240424-628.\nPlease contact us with any questions or concerns:\nPublic Recall Contact: Customer Service\n\nAddress:\nApplied Medical Technology, Inc.\nAttn: Customer Service\n8006 Katherine Blvd\nBrecksville, OH 44141\nUSA\nTelephone: 440-717-4000\nFax: 440-717-4200\nEmail: cs@appliedmedical.net\nGeneral hours of operation are 8:30am to 5:00pm. All times in Eastern Standard Time Zone.", "product_quantity": "100", "distribution_pattern": "US Distribution to states of: CA, CT, FL, GA, IL, MA, MD, MO, NC, NJ, NY, OH, OK, PA, SC, TX, VA, WA", "openfda": { "k_number": [ "K190310", "K181276", "K210971", "K141753", "K142989", "K210598", "K230326", "K201741", "K151503", "K190327", "K150679", "K213356", "K150286", "K150711", "K200082", "K140947", "K171347", "K161003", "K153688", "K160642", "K170162", "K181787", "K203633", "K223683", "K240052", "K142539", "K142297", "K213258", "K202357", "K142012", "K143018", "K213174", "K232046", "K142075", "K242917", "K192991", "K233034", "K190414", "K191759", "K222773", "K150084", "K250481", "K190923", "K180708", "K191784", "K163586", "K222678", "K210854", "K254170", "K170555" ], "device_name": "Gastrointestinal Tubes With Enteral Specific Connectors", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5980", "device_class": "2", "registration_number": [ "2029015", "3005099803", "3013298431", "1417592", "3008044552", "3009247326", "8030107", "2025851", "3007590959", "1828132", "9610849", "2080225", "3007138831", "3014421917", "3015433750", "3014637079", "3034669683", "3017081712", "3014662855", "3010017366", "3017509841", "3006673317", "3015276780", "1526012", "1000121056", "1225687", "1419562", "2032112", "3012104670", "3027341532", "1048735", "3007441619", "3008311916", "3005574598", "3010972758", "3008102042", "3008448733", "1921846", "3012881740", "8010042", "8044099", "3003593728", "3005210579", "1722139", "3015997711", "3018366470", "3009988302", "3005674464", "3001124136", "3011270181", "9680425", "3010400865", "3004906872", "1423537", "3014926389", "3010131137", "3005458990", "3014656668", "8022978", "1066607", "3031190571", "3013557562", "3015462350", "1058397", "3012169247", "3011987967", "3007289408", "3005670221", "3014615028", "3003965134", "3008806809", "3016884033", "1000317571", "9612030", "3005580113", "9618003", "3007766601", "3014016859", "3017607339", "3010273872", "3004784537", "3003903031", "9681260", "3008058400", "9613419", "3004472854", "3016171914" ], "fei_number": [ "3005099803", "3001236905", "3013298431", "3001451463", "1417592", "3008044552", "3009247326", "2025851", "3007590959", "3002807391", "3005596530", "1828132", "2080225", "3007138831", "3014421917", "3015433750", "3014637079", "3034669683", "3017081712", "3014662855", "3010017366", "3017509841", "3015276780", "3003282547", "1526012", "3003076831", "1000121056", "3007596547", "1419562", "3012104670", "3027341532", "1000158532", "1048735", "3007441619", "3008311916", "3002806565", "1000117172", "3005574598", "7682", "3010972758", "3002808128", "3008448733", "1921846", "1000160458", "3003264198", "3012881740", "3003593728", "3005210579", "3015997711", "3018366470", "3009988302", "3005674464", "3001124136", "3011270181", "3000168341", "3010400865", "3004906872", "3014926389", "3010131137", "3005458990", "3014656668", "3031190571", "3002806934", "3013557562", "3015462350", "3012169247", "3011987967", "3007289408", "3005670221", "3014615028", "3003965134", "3008806809", "3016884033", "3002924544", "1000317571", "3005580113", "3007766601", "3014016859", "3017607339", "3010273872", "3004784537", "3003903031", "3006582718", "3008058400", "3004472854", "3004458261", "3016171914" ] } } ] }