{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "149835", "product_res_number": "Z-0241-2017", "event_date_initiated": "2015-04-22", "event_date_created": "2016-10-20", "recall_status": "Terminated", "event_date_terminated": "2016-10-25", "res_event_number": "71968", "product_code": "FSY", "product_description": "Minor Ortho Pack, Kit number 002646-12 and 002646-13\n\nconvenience custom kits used for general surgery in hospital operating room", "code_info": "Lot Numbers/ Expiration Dates:  59453\t8/2/2013 58726\t8/21/2013 62658\t12/11/2013 63489\t12/17/2013 61162\t12/21/2013 60183\t12/29/2013 65535\t1/31/2014 66430\t1/31/2014 66807\t1/31/2014 61804\t2/7/2014 67876\t9/5/2014 64144\t9/7/2014 64457\t9/30/2014 64909\t9/30/2014 69781\t5/2/2016 68945\t5/10/2016 71058\t6/4/2016 57425\t6/28/2016", "firm_fei_number": "1000125955", "recalling_firm": "Windstone Medical Packaging, Inc.", "address_1": "1602 4th Ave N", "city": "Billings", "state": "MT", "postal_code": "59101-1521", "additional_info_contact": "Vicki Davis\n406-259-6387", "reason_for_recall": "The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.", "root_cause_description": "Unknown/Undetermined by firm", "action": "Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.\n\nConsignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes. \n\nConsignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution. \n\nAMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.\n\nDue to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:\n\nRECALL NOTICE\nMedtronic announced the recall l of Devon Light Glove contained in this kit\nafter it was sealed and sterilized. All other components in the kit are not\naffected by this recall.\n\n1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside\n\n2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.\n\nConsignees should complete the attached Reply Form and fax to AMS at 406-256-9875.\n\nFor any questions about this recall, please call 321-527-7714.\nFor questions regarding this recall call 404-259-6387.", "product_quantity": "352 kits", "distribution_pattern": "Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.", "openfda": { "k_number": [ "K140812", "K860739", "K040735", "K101537", "K922836", "K961843", "K071698", "K002463", "K132551", "K142984", "K992090", "K140930", "K142076", "K060802", "K873786", "K982063", "K042382", "K131893", "K990656", "K024132", "K902864", "K944855", "K943288", "K901830", "K896674", "K984611", "K031979", "K090378", "K781887", "K132307", "K974084", "K854922", "K040015", "K963682", "K981081", "K900211", "K031068", "K000639", "K010716", "K083323", "K140461", "K820681", "K771865", "K102758", "K140460", "K122875", "K965130", "K993242", "K100702", "K093010", "K083066", "K915285", "K132747", "K072072", "K011693", "K070442", "K021585", "K891757", "K914076", "K891756", "K042395", "K080857", "K954169", "K892808", "K974433", "K904965", "K063333", "K093009", "K030906", "K991527", "K973466", "K780666", "K061317", "K120392" ], "registration_number": [ "3006437518", "1423537", "1825014", "3012092534", "3044829820", "3026390991", "3015131225", "3005698350", "9681407", "1225473", "8010153", "9710055", "3042970964", "3011137372", "1921846", "3030558088", "3025628903", "3007682310", "3020703842", "1043572", "3011910987", "3035641086", "3006223081", "2031963", "3010726901", "3002821232", "3029970239", "3042992004", "3010041511", "9680506", "3031700059", "1066270", "3007591382", "3031563141", "3011580044", "3007143268", "3009129579", "3017970309", "3027847726", "3011574775", "1066635", "3012272052", "1054713", "9612030", "3042991836", "3009028104", "3015468226", "3011644607", "3009061550", "9617655", "1017294", "3029936435", "3002532594", "3033527731", "3021839632", "9710585", "1000122786", "3003574554", "3000286616", "3009542956", "1836161", "3007238566", "3023808059", "9710098", "3015223105", "9611503", "3012165496", "3030516433" ], "fei_number": [ "1000182014", "3006437518", "1825014", "1000396729", "3025504317", "3002750084", "3044829820", "3026390991", "3015131225", "3005698350", "3002808335", "3001237319", "3030516433", "3001236905", "3042970964", "1921846", "3030558088", "3025628903", "3020703842", "1000214453", "1043572", "3011910987", "3035641086", "3000957797", "3006223081", "3010726901", "3002821232", "3029970239", "3003184737", "3042992004", "3010041511", "3006125657", "3031700059", "3007591382", "3031563141", "3002465150", "3011580044", "3007143268", "3009129579", "3017970309", "3027847726", "3011574775", "3042991836", "3012272052", "3009028104", "3002975342", "3015468226", "3011644607", "3009061550", "1000125341", "3005747797", "1017294", "3002806934", "3029936435", "3002532594", "3033527731", "1000122786", "3003574554", "3000286616", "3009542956", "3007238566", "3023808059", "3015223105", "1000114111", "3003779679", "3012165496", "3002957101", "3002939620" ], "device_name": "Light, Surgical, Ceiling Mounted", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4580", "device_class": "2" } } ] }