{ "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": "114152", "product_res_number": "Z-0407-2013", "event_date_initiated": "2012-08-17", "event_date_posted": "2012-11-20", "recall_status": "Terminated", "event_date_terminated": "2013-06-14", "res_event_number": "63532", "product_code": "KAK", "k_numbers": [ "K822277", "K925791", "K944949" ], "product_description": "Vital Signs Disposable General Purpose 9 French Temperature Probe\nFor monitoring of core temperature", "code_info": "Model Numbers 1016, 1016EU, R1016ES; GXXXX64 All units Made in Costa Rica are affected Lot Numbers:    12089A\t12131A\t  5575A\t5586X\t5633U\t5664E\t5685G\t5712T  12090B\t12138A\t5578K\t5603R\t5636Y\t5666R\t5685H\t 5714Z  12100A\t12157B\t5578L\t5606U\t5638P\t5668N\t5685J\t 12101B\t12173A\t5580Y\t5614N\t5638Q\t5669G\t5689Y\t 12102A\t5573Q\t5580Z\t5615N\t5648T\t5669H\t5691T\t 12108B\t5574A\t5581A\t5621U\t5648U\t5671D\t5692H\t 12109B\t5574B\t5581L\t5623H\t5653Z\t5673V\t5696Q\t 12114B\t5574X\t5583E\t5631C\t5658D\t5683V\t5700J\t 12117B\t5574Y\t5584C\t5632V\t5660C\t5683W\t5703N\t 12130B\t5574Z\t5584D\t5633T\t5664D\t5683X\t5708R", "firm_fei_number": "1718887", "recalling_firm": "Vital Signs Colorado Inc.", "address_1": "11039 East Lansing Circle", "city": "Englewood", "state": "CO", "postal_code": "80112-5909", "additional_info_contact": "Ms. Gwen Braeger\n262-548-2608", "reason_for_recall": "There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe.", "root_cause_description": "Device Design", "action": "The firm,GE Healthcare, sent an \"URGENT MEDICAL DEVICE CORRECTION\" letter and Confirmation form on August 17, 2012 via Fed Ex to its consignees/customers. The letter describes the product, problem and action to be taken. The customers were instructed to do the following: Do not use the Disposable General Purpose 9 French Temperature Probe P/N 1016 or 1016EU; return all unopened product(s) to Vital Signs Devices (VSD) 11039 East Lansing Circle, Englewood, CO 80112-note: replacements and/or refunds discussed in letter are available only in exchange for the return of any unopened product(s); complete and return the URGENT MEDICAL DEVICE CORRECTION CONFIRMATION via fax to: 800-535-7923; forward a copy of the letter to any institutions they may have forwarded the product and for customers using the GXXXXX64 kit that includes the Disposable General Purpose 9 French Temperature Probe follow the directions listed in the letter.\n\nNote: VSD is removing p/n 1016 and 1016EU, Disposable General Purpose 9 French Temperature Probe, from the market and offering a replacement. \n\nIf you have any questions or concerns regarding this notification, contact Customer Service at +1-800-932-0760 (Domestic & International). Hours of Operation 8:00 am EST to 6:00 pm EST.", "product_quantity": "243,685 units", "distribution_pattern": "Worldwide distribution: USA (nationwide) including states of: AR, CA, FL,GA, IL, LA, MA, MI, MO, NC, NH, NY, OH, OK, PA, RI, SE,TX, and WA; and countries of: AUSTRALIA, BARCELONA, GERMANY, NEW ZEALAND, NETHERLANDS, SWITZERLAND, and UNITED KINGDOM.", "openfda": { "registration_number": [ "3005528784", "3005067367", "1417592", "3007773213", "3003418325", "9616250", "9611827", "9610612", "3013247477", "9613083", "3030644259", "8040233", "1720747", "8010374", "3001084743", "9615005", "3010202439", "3004215117", "9611112", "9615857", "2080783", "3013501110", "3031564283", "9680837", "3027187888", "3009513193", "3007507973", "3010455030", "3012267976", "3011600579", "3009255580", "3005440795", "8043507", "8010433", "1056350", "9710524", "9611102", "3013497507", "1926681", "3004892425", "3006154292", "1314417", "9610773", "3004608878", "3006554912", "3010041511", "3023657851", "8040172", "8010099", "3043355002", "1421101", "3016965929", "3002858762", "3003435550", "9611252", "1313525", "3003877407", "3014334038", "1836161", "3002976036", "9680718", "3008770252", "3010726901", "3004530184", "3005809810", "1923569", "1526854", "3021680161", "3004001706", "8030607", "3003761012", "9613926", "8044098", "3011585752", "1932180", "8040278", "3004571672", "3008280196", "1421879", "3016852448", "3008797953", "3002807115", "8010372", "3012507533", "2916714", "1123137", "3011137372", "2529846", "9615004", "3015451162", "3007878094" ], "fei_number": [ "1000115048", "3005747797", "3005528784", "1417592", "1000402972", "3007773213", "3003418325", "3003772581", "3013247477", "3030644259", "1000136191", "3004028763", "1720747", "3001084743", "3002806315", "3010034765", "3004215117", "3004216008", "2080783", "3013501110", "3031564283", "3027187888", "3000280067", "3009513193", "3002808360", "3010455030", "3012267976", "3011600579", "3002750084", "3009255580", "3005440795", "3006509795", "3003249645", "3008782585", "3003499455", "3013497507", "1926681", "3004892425", "3006154292", "3001286223", "1314417", "3003944071", "3004608878", "3002807798", "3006554912", "3010041511", "3023657851", "3043355002", "1421101", "3016965929", "3546", "3005693456", "3002858762", "3002807421", "3003435550", "3007475226", "3003877407", "3014334038", "3002976036", "5870", "1000119305", "3008770252", "3010726901", "3004530184", "3005809810", "1923569", "3002807720", "1526854", "3021680161", "3003200061", "3004001706", "3003761012", "3011585752", "3000041196", "3007290840", "1000140363", "3002806612", "3004571672", "3008280196", "3016852448", "3008797953", "3001130644", "3002807115", "3012507533", "2916714", "1000123180", "1317628", "3002409980", "3015451162", "3002808001", "3007878094" ], "k_number": [ "K822277" ], "device_name": "Probe, Ent", "medical_specialty_description": "Ear, Nose, Throat", "regulation_number": "874.4420", "device_class": "1" } } ] }