{ "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": "167154", "product_res_number": "Z-0088-2019", "event_date_initiated": "2018-08-30", "event_date_created": "2018-10-06", "recall_status": "Terminated", "event_date_terminated": "2023-02-09", "res_event_number": "80972", "product_code": "NEC", "product_description": "Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine, Item Numbers: a) NONUNNA3 and b) NONUNNA4\n\nProduct is packaged in a foil pouch, which is inserted in a box carton. There are 12 cartons in each case.", "code_info": "Lot numbers: a) NONUNNA3: 70112, 70485, 70602, 80637, 80663, and 80719. b) NONUNNA4: 70182, 70593, 80638, 80644, 80660, 80709 and 80712.", "firm_fei_number": "1417592", "recalling_firm": "MEDLINE INDUSTRIES INC", "address_1": "3 Lakes Dr", "city": "Northfield", "state": "IL", "postal_code": "60093-2753", "additional_info_contact": "Kassandra Cotner\n866-359-1704", "reason_for_recall": "Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold.", "root_cause_description": "Environmental control", "action": "On August 30, 2018, Medline sent Immediate Action Required letters to all of their consignees. Each letter was accompanied by an Urgent Remedial Action Destruction Form which was to be completed and returned to the firm.", "product_quantity": "113,302 units", "distribution_pattern": "United States, Taiwan, Chile", "openfda": { "k_number": [ "K861558", "K861557", "K972081" ], "registration_number": [ "1063707", "3003807757", "3008174904", "3009655869", "3023464160", "3019585803", "3014204518", "3016525500", "3005083505", "1130591", "3010657142", "1417592", "9616872", "8020152", "3030181830", "1423662", "2110898", "3016450032", "3017048841", "3014610488", "9610694", "3003799320", "3014421917", "3004615451", "9616874", "3034629649", "3010827261", "3025585194", "2320961", "3015140199", "3033435697", "9616572", "3007187674", "3036978602", "1526711", "3010623099", "3005343641", "3009746061", "3010374972", "2438948", "3012907824", "3016710934", "3004111573", "8030128", "3016449659", "3012430748", "3010198795", "3007124979", "3026263452", "3011558220", "3008808082", "3004617746", "3007125336", "3016452400", "3018101380", "3007594734", "3016603542", "9680143", "3015821396", "1067168", "3008262278", "3008261762", "1413547", "3017231740", "3004380247", "3010966625", "3030733800", "3010605379", "1054811", "3034605486", "3012494290", "3005273623", "3002647523", "3035479692", "3016901080", "3045924479", "3006517436", "3017036472", "3004512585", "3045058049", "2280705", "3017140435", "1043214", "3017633586", "3030398124", "3007766648", "3010275504", "3010034780", "8022978", "2110420", "3015142802", "3010131715", "3017417635", "1480288", "3042158718", "3008374791", "3010034760", "8032044", "3031180770", "3014570707", "3007417776", "3045077830", "2125337", "3013557562", "1000221288", "3007648359", "3003428492", "3044859293", "3015172365", "3011987967", "3014146451", "3038599932", "3016649599", "3006506075", "8043484", "3022764539", "1018233", "1055236", "1649690", "3008806809", "3006638854", "3016904853", "3004472810", "1420054", "3030087693", "1722458", "3010374920", "3008132238", "3006897996", "3042896810", "3038283966", "3010173425", "3012910884", "3003915875", "3016970619", "9680794", "1054241", "3000256895", "3017297225", "2320762", "3030067857", "3014579161", "3031700076", "3011191255", "3010223109" ], "fei_number": [ "3003807757", "3008174904", "3009655869", "3023464160", "3019585803", "3014204518", "3016525500", "3005083505", "1130591", "3010657142", "1417592", "3003040625", "3030181830", "2110898", "3001451826", "3016450032", "3014610488", "3003799320", "3014421917", "3004615451", "3034629649", "3010827261", "3003172243", "3025585194", "3015140199", "3033435697", "3002807036", "3007187674", "3036978602", "1526711", "3010623099", "3005343641", "3009746061", "3010374972", "3012907824", "3016710934", "3004111573", "3016449659", "3012430748", "3010198795", "3007124979", "3026263452", "2434554", "3011558220", "3008808082", "3004617746", "3007125336", "3016452400", "3006118668", "3018101380", "3007594734", "3016603542", "3015821396", "3008262278", "3017231740", "3004380247", "3010966625", "3030733800", "3010605379", "3034605486", "3012494290", "3002807308", "3005273623", "3002647523", "3005669319", "3006403682", "3035479692", "3016901080", "1000114185", "3045924479", "3006517436", "3017036472", "3004512585", "3045058049", "2280705", "3017140435", "1043214", "3017633586", "1000112968", "3030398124", "3007766648", "3010275504", "3010034780", "2110420", "3003737899", "3015142802", "3010131715", "3017417635", "1480288", "3000215273", "3008374791", "3010034760", "3042158718", "1000138447", "3031180770", "3002808194", "3014570707", "3007417776", "3045077830", "3002806731", "2125337", "3013557562", "1000221288", "3007648359", "3005310494", "3004158845", "3003428492", "3044859293", "3015172365", "3011987967", "3014146451", "3038599932", "3016649599", "3006506075", "3022764539", "3002806269", "1018233", "1000112877", "3008806809", "3001698565", "3016904853", "1420054", "3030087693", "1000110937", "3002638508", "3010374920", "3008132238", "3002897187", "3006897996", "3042896810", "6036", "3038283966", "3012910884", "3003915875", "3016970619", "3000256895", "3006582718", "3017297225", "3003396642", "3030067857", "3014579161", "3031700076", "3003661715", "3011191255", "3010223109" ], "device_name": "Bandage, Liquid, Skin Protectant", "medical_specialty_description": "General Hospital", "regulation_number": "880.5090", "device_class": "1" } } ] }