{ "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": "141973", "product_res_number": "Z-0415-2016", "event_date_initiated": "2015-11-20", "event_date_created": "2015-12-14", "recall_status": "Terminated", "event_date_terminated": "2016-08-22", "res_event_number": "72682", "product_code": "PIF", "k_numbers": [ "K142539" ], "product_description": "Catalog No. INF0020-A EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector (spiked set); Catalog No. INF0500-A - 500ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No INF1200-A - 1200ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No GR1200-A 1200ml Enteral Feeding Delivery Set with ENFit Connector System and Transitional Stepped Connector (gravity set).\n\nUsed to dispense liquid nutrients at a preprogrammed pump or user controlled rate.", "code_info": "All EnteraLite Infinity Enteral Pump Delivery Sets with ENFit connector System and transitional Stepped Connector.", "firm_fei_number": "1000117172", "recalling_firm": "MOOG Medical Devices Group", "address_1": "4314 S Zevex Park Ln", "city": "Salt Lake City", "state": "UT", "postal_code": "84123-7881", "additional_info_contact": "Christopher Dodge\n801-264-1001", "reason_for_recall": "Potential for leaking between the purple ENFit connector and the white transitional stepped connector due to cracking or breaking of the purple connector.", "root_cause_description": "Unknown/Undetermined by firm", "action": "MOOG Medical sent an URGENT Field Safety Notice, dated November 20, 2015, to its customer. The letter identified the affected device, provided a description of the problem, and discussed the risk to health. The customer was asked to contact all known distributors and inform them that MOOG Medical will cease production of all its enteral administration sets using ENFit connectors and transition back to the previous revision of the product codes that do not include the ENFit connector (INF0020, INF0500, INF1200, and GR1200). MOOG Medical will produce the previous revision until a solution to the problem is found. All necessary users should be made aware of the notice. Christopher Dodge, Manager, Regulatory Affairs, should be contacted with questions or for additional info at 801-264-1001, ext. 112 or cdodge@moog.com.", "product_quantity": "12,014,130 sets", "distribution_pattern": "Distributed to the state of MN.", "openfda": { "k_number": [ "K160642", "K232046", "K170555", "K151503", "K200082", "K170162", "K142989", "K181276", "K201741", "K190327", "K223683", "K222678", "K213258", "K163586", "K140947", "K210854", "K143018", "K150711", "K242917", "K142012", "K250481", "K150679", "K240052", "K254170", "K191784", "K141753", "K150286", "K210598", "K222773", "K190414", "K213174", "K230326", "K142539", "K150084", "K142297", "K202357", "K192991", "K190923", "K233034", "K180708", "K213356", "K203633", "K153688", "K171347", "K161003", "K190310", "K181787", "K191759", "K142075", "K210971" ], "registration_number": [ "3008044552", "3009247326", "3005574598", "3005580113", "3008448733", "3004784537", "9681260", "8022978", "3010400865", "9613419", "3014662855", "3007590959", "3015276780", "3014637079", "9612030", "3027341532", "1000121056", "3007441619", "3034669683", "3012104670", "1058397", "3007289408", "3005674464", "3017081712", "3010017366", "3015997711", "9618003", "3003903031", "3017607339", "3004472854", "3013557562", "2025851", "3011987967", "8010042", "9680425", "3014615028", "3010972758", "3008102042", "3010131137", "3008058400", "3001124136", "1066607", "3004906872", "2032112", "3005670221", "3013298431", "3008311916", "3015462350", "1417592", "1921846", "1526012", "1048735", "3031190571", "3018366470", "3014926389", "2029015", "3005458990", "3003593728", "3011270181", "3015433750", "3017509841", "8030107", "1225687", "3014656668", "9610849", "3016171914", "1423537", "1828132", "3007138831", "3005099803", "3016884033", "3010273872", "3008806809", "3009988302", "2080225", "1722139", "3007766601", "3014421917", "1419562", "3005210579", "3014016859", "3012881740", "1000317571", "3003965134", "3006673317", "8044099", "3012169247" ], "fei_number": [ "3008044552", "3009247326", "3005574598", "3005580113", "3003282547", "3008448733", "3004784537", "3010400865", "3014662855", "3007590959", "1000160458", "3015276780", "3014637079", "7682", "3003264198", "3002924544", "3005596530", "3027341532", "1000121056", "3007441619", "3003076831", "3034669683", "3012104670", "3007289408", "3005674464", "3017081712", "3010017366", "3015997711", "3003903031", "3001236905", "3017607339", "3004472854", "3013557562", "2025851", "3011987967", "3004458261", "3014615028", "1000117172", "3010972758", "3010131137", "3008058400", "3001124136", "3006582718", "1000158532", "3004906872", "3005670221", "3013298431", "3008311916", "3015462350", "1417592", "3002806934", "1921846", "1526012", "1048735", "3031190571", "3018366470", "3007596547", "3014926389", "3005458990", "3003593728", "3002806565", "3011270181", "3015433750", "3000168341", "3017509841", "3014656668", "3001451463", "3016171914", "1828132", "3007138831", "3005099803", "3016884033", "3002807391", "3010273872", "3008806809", "3009988302", "2080225", "3002808128", "3007766601", "3014421917", "1419562", "3005210579", "3014016859", "3012881740", "1000317571", "3003965134", "3012169247" ], "device_name": "Gastrointestinal Tubes With Enteral Specific Connectors", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5980", "device_class": "2" } } ] }