{ "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": "86950", "product_res_number": "Z-0782-2010", "event_date_initiated": "2009-11-14", "event_date_posted": "2010-02-04", "recall_status": "Terminated", "event_date_terminated": "2012-01-25", "res_event_number": "53947", "product_code": "ILO", "product_description": "TempPad Cold Therapy Pad.\n\nThe device is used for localized temperature therapy including hand, elbow, arm, foot, ankle, leg, or knee.", "code_info": "Part #: 50625, Catalog number: 510-US, Lot #: 08296, 08529, 08530, 08531, 08674, 08759, 08826, 08952, 09052, 09166, 09422, 09423; Part #: 50633, Catalog #: 510-USS, Lot #: 08537, 08675, 08953; Part #: 50627, Catalog #: 814-US, Lot #: 08610; Part # 50634, Catalog # 814-USS, Lot #: 08611, 08919, 09466; Part #: 50628, Catalog #: 1112-US, Lot #'s: 08382, 08411, 08475, 08476, 08477, 08557, 08583, 08657, 08666, 08667, 09486, 08668, 08707, 08771, 08810, 08874, 08903, 08971, 09037, 09088, 09089, 09149, 09225, 09251, 09285, 09313, 09314, 09327, 09360, 09361, 08320; Part #:50635, Catalog #: 1112-USS, Lot #'s: 08410, 08514, 08606, 08673, 08708, 08772, 08802, 08868, 08954, 09017, 09066, 09067, 09195, 09253, 09254, 09295, 09377, 09378, 09485, 08331; Part #: 50629, Catalog #: 1215-US, Lot #'s: 08395, 08584, 08669, 08732, 08917, 08989, 09107, 09218 & Part #: 50137, and Catalog #: CT-99, Lot #'s: 08332, 08353, 08438, 08538, 08607, 08608, 08706, 08725, 08773, 08837, 08851, 08879, 08933, 08970, 09010, 09086, 09087, 09143, 09144, 09157, 09294, 09329, 09362, 09379 and 08423.", "firm_fei_number": "1516825", "recalling_firm": "Cincinnati Sub-Zero Products Inc", "address_1": "12011 Mosteller Rd", "city": "Cincinnati", "state": "OH", "postal_code": "45241-1528", "additional_info_contact": "Kristine Gilkey\n513-772-8810", "reason_for_recall": "Product is labeled as \"Sterile\". It was observed that incomplete seals were created in the packaging materials during production. When the seal is compromised, the sterility of the product inside the package cannot be assured.", "root_cause_description": "Other", "action": "On November 14, 2009, Cincinnati Sub-zero Products, Inc. (CSZ) sent a recall notification letter and response letter to customers. A second notice dated December 10, 2009 was also issued to customers. Customers were instructed in the notifications to assume the recalled product is not sterile and do not use. CSZ requested all affected product be returned to their firm for replacement. Customers are to complete and return the response letter acknowledging receipt of the recall letter. Direct questions to CSZ by calling Customer Service at 1-800- 989-7373. Customers may also call 1-800-989-7373, extension 3234 or 1-51 3-71 9-3234 for recall instructions. Representatives will be available to take your call from 8:30 a.m. until 4:30 p.m. eastern standard time, Monday through Friday.", "product_quantity": "8,872 cartons of ten + 677 each (89,397 total)", "distribution_pattern": "Worldwide Distribution -- United States (AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI & WV), Canada, France, Germany, Ireland, Israel, New Zealand, Singapore, and The Netherlands.", "openfda": { "k_number": [ "K925677", "K801301", "K884255", "K891091", "K900356", "K923643", "K964354", "K961855", "K760804", "K832820", "K891603", "K955326", "K955057", "K962537", "K963261", "K926151", "K945067", "K915196", "K944971", "K945853", "K904998", "K760910", "K930918", "K970533", "K940160", "K890852", "K940429", "K761254", "K832819", "K072152", "K902269", "K953532", "K760782", "K891152", "K893706", "K040317", "K921540", "K945399", "K830757", "K890853", "K902268", 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"2011068", "3031646688", "3011191255", "3017202421", "3000210417", "3011767724", "3008236846", "3042277508" ], "device_name": "Pack, Hot Or Cold, Water Circulating", "medical_specialty_description": "Physical Medicine", "regulation_number": "890.5720", "device_class": "2" } } ] }