{ "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": "130410", "product_res_number": "Z-0499-2015", "event_date_initiated": "2014-09-26", "event_date_posted": "2014-12-04", "recall_status": "Terminated", "event_date_terminated": "2016-10-03", "res_event_number": "69394", "product_code": "MGQ", "k_numbers": [ "K971918" ], "product_description": "Amerigel Daily Dressing Packets\n\nWound management", "code_info": "Model # A2003, Lot #s: 2WD07", "firm_fei_number": "1000525408", "recalling_firm": "Amerx Health Care Corp.", "address_1": "1300 S. Highland Avenue", "city": "Clearwater", "state": "FL", "postal_code": "33756", "additional_info_contact": "James B. Anderson\n727-443-0530", "reason_for_recall": "Formulation deviation", "root_cause_description": "Mixed-up of materials/components", "action": "Amerx Health Care Corporation sent an URGENT: DEVICE RECALL letter instructing consignees to examine their inventory and immediately determine if they have any of the Lot numbers on hand and to quarantine the product subject to recall. In addition, if they may have further distributed the product, please notify their customers and/or post the enclosed letter in a visible location for the customer to read. Customers with questions were instructed to call 800-448-9599 or email recall@amerxhc.com.\nFor questions regarding this recall call 727-443-0530.", "product_quantity": "1740", "distribution_pattern": "Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, WV, Virgin Islands, Puerto Rico, Guam, Hawaii and District of Columbia and Internationally to: Canada, England, Africa, and Australia.", "openfda": { "k_number": [ "K990368", "K911550", "K022587", "K993119", "K962218", "K965143", "K990178", "K940814", "K022995", "K970153", "K922815", "K002078", "K083024", "K933817", "K935203", "K953853", "K980962", "K983042", "K945835", "K990179", "K992074", "K915002", "K970453", "K964620", "K002666", "K171879", "K973693", "K935096", "K983362", "K022584", "K962160", "K964240", "K982825", "K954741", "K961067", "K920050", "K980132", "K943470", "K041268", "K990180", "K002129", "K961758", "K955575", "K934267", "K020325", "K945313", "K926389", "K952247", "K982306", "K953505", "K982577", "K961766", "K913344", "K971918", "K943728", "K984370", "K946031", "K973722", "K943910", "K932291", "K010583", "K932101", "K040517", "K991202", "K952774", "K932263", "K963004", "K011994", "K952276", "K912667", "K961085", "K946030", "K926353", "K942419", "K003396", "K002077", "K952938", "K953816", "K954664", "K973725", "K932973", "K000518", "K952775", "K952419", "K961316", "K941339", "K945217", "K000519", "K962089", "K955400", "K984262", "K962851", "K984266", "K951861", "K984413", "K970693", "K984082", "K961930", "K041342", "K960428", "K982804", "K980097", "K964468", "K940409", "K945005", "K980861", "K991755", "K960686", "K920554", "K990440", "K933328", "K013525", "K920642", "K915001", "K951417", "K953450", "K954384", "K944427", "K964241", "K024054", "K962439", "K921810", "K962513", "K040019", "K973721", "K942798", "K970133", "K974251", "K953669", "K024367", "K965005", "K973724", "K930560", "K951862", "K943073", "K933495", "K950934", "K984368", "K984264", "K981150", "K984267", "K973806", "K914746", "K944333", "K962917" ], "registration_number": [ "1063707", "1055236", "3031168520", "9680091", "3005465238", "1649690", "3012535730", "1058584", "3013298431", "2135152", "3023548698", "2029275", "1036836", "3015528146", "3016807311", "1417592", "3006052875", "8044046", "1219103", "1423537", "1646434", "1043214", "2132242", "9610200", "3003636207", "3010143501", "1419520", "3005488444", "3016096134", "1649518", "3010315629", "1219592", "9610694", "3007048057", "3012979524", "1054241", "3005689226", "9680143", "3008770963", "1018120", "2320762", "1061124", "2125337", "3013557562", "3024971708", "3012263097", "3010287685", "3009882464", "3014579161", "3006784948", "1921846", "1034876", "3011276993" ], "fei_number": [ "1000219637", "3031168520", "3001236277", "3005465238", "1000112877", "3001236905", "3002806986", "3012535730", "3013298431", "3023548698", "3002807308", "1000143837", "3001698565", "1036836", "3015528146", "3016807311", "1417592", "3006052875", "1000306431", "3003040625", "1043214", "1000112968", "3002806830", "3010598187", "3003636207", "3010143501", "1419520", "3005488444", "3001451826", "3016096134", "3010315629", "1219592", "1000512168", "1000138377", "3007048057", "3012979524", "3005689226", "3008770963", "1018120", "3002806731", "2125337", "3013557562", "3024971708", "3012263097", "3008162665", "3010287685", "3009882464", "3014579161", "3006784948", "1921846", "1034876", "1000148701", "3011276993" ], "device_name": "Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "U" } } ] }