{ "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": "149939", "product_res_number": "Z-0284-2017", "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": "Virginia Custom Pack, Kit number RMS1744\n\nconvenience custom kits used for general surgery in hospital operating room", "code_info": "Lot Numbers/ Expiration Dates:  59798\t9/26/2014 59796\t7/5/2015 59797\t7/5/2015 61329\t7/5/2015 60411\t8/5/2015 61222\t9/1/2015 60758\t9/9/2015 66544\t11/5/2015 66261\t11/7/2015 64654\t11/8/2015 61679\t11/9/2015 63209\t11/13/2015 62471\t11/17/2015 61678\t11/27/2015 65932\t11/30/2015 62470\t12/9/2015 63208\t12/18/2015 63927\t1/5/2016 64653\t1/7/2016 64307\t1/18/2016 63926\t1/20/2016 68195\t7/5/2016 68638\t7/7/2016 67670\t7/16/2016 66545\t7/23/2016 69868\t9/15/2016 69907\t9/17/2016 68874\t9/25/2016 70705\t10/25/2016 69039\t10/27/2016 70945\t12/5/2016 70704\t1/4/2017 71513\t1/27/2017 71688\t3/6/2017 71840\t3/6/2017 73729\t4/17/2017 73177\t4/20/2017 73393\t4/21/2017 73731\t5/16/2017 74648\t5/30/2017 75024\t7/3/2017 75160\t7/11/2017 75975\t7/21/2017 76242\t8/3/2017 76441\t8/18/2017 77269\t8/22/2017 78308\t9/26/2017 77268\t10/8/2017 78593\t11/4/2017 79038\t11/20/2017 79881\t1/7/2018 79039\t2/28/2018", "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": "5388 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" } } ] }