{ "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": "2026-03-18", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Ongoing", "city": "Mansfield", "state": "MA", "country": "United States", "classification": "Class I", "openfda": {}, "product_type": "Devices", "event_id": "90311", "recalling_firm": "Covidien Llc", "address_1": "15 Hampshire St", "address_2": "N/A", "postal_code": "02048-1113", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, DC, GU, & PR. The countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kosovo, Kuwait, Lebanon, Luxembourg, Macao, Malaysia, Maldives, Malta, Mayotte, Mexico, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, North Macedonia, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, United States, Viet Nam, Virgin Islands, and Zimbabwe.", "recall_number": "Z-1317-2022", "product_description": "Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.", "product_quantity": "26,474 units", "reason_for_recall": "There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.", "recall_initiation_date": "20220608", "center_classification_date": "20220707", "report_date": "20220713", "code_info": "Code Information organized as \"Model No., Serial No., GTIN\": 8888119365, 1925200097, 20884521012810; 8888119371, 2031800117, 20884521056562; 8888123405, 2028200168, 20884521012940; 8888123405, 2127200428, 20884521012940; 8888145043, 1932200082, 10884521013223; 8888145043, 2003700042, 10884521013223; 8888145043, 2014900147, 10884521013223; 8888145043, 2023300169, 10884521013223; 8888145043, 2031800113, 10884521013223; 8888145043, 2034400185, 10884521013223; 8888145043, 2104600104, 10884521013223; 8888145043, 2108100054, 10884521013223; 8888145043, 2127200539, 10884521013223; 8888145043, 1919700110, 20884521013220; 8888145043, 1929500076, 20884521013220; 8888145043, 1932200082, 20884521013220; 8888145043, 2000700103, 20884521013220; 8888145043, 2003700042, 20884521013220; 8888145043, 2014900147, 20884521013220; 8888145043, 2019200001, 20884521013220; 8888145043, 2023300169, 20884521013220; 8888145043, 2028200174, 20884521013220; 8888145043, 2031800112, 20884521013220; 8888145043, 2031800113, 20884521013220; 8888145043, 2034400185, 20884521013220; 8888145043, 2034400187, 20884521013220; 8888145043, 2104600100, 20884521013220; 8888145043, 2104600104, 20884521013220; 8888145043, 2108100054, 20884521013220; 8888145043, 2108100055, 20884521013220; 8888145043, 2108100056, 20884521013220; 8888145043, 2109700070, 20884521013220; 8888145043, 2116500163, 20884521013220; 8888145043, 2124500119, 20884521013220; 8888145043, 2127200539, 20884521013220; 8888145043, 2127200540, 20884521013220; 8888145043, 2127200541, 20884521013220; 8888145044, 1922500109, 10884521013247; 8888145044, 1922500112, 10884521013247; 8888145044, 1925200063, 10884521013247; 8888145044, 1933700119, 10884521013247; 8888145044, 2000700104, 10884521013247; 8888145044, 2104600101, 10884521013247; 8888145044, 2106900137, 10884521013247; 8888145044, 2110900104, 10884521013247; 8888145044, 2113400084, 10884521013247; 8888145044, 2116200117, 10884521013247; 8888145044, 2200300118, 10884521013247; 8888145044, 1922500109, 20884521013244; 8888145044, 1922500110, 20884521013244; 8888145044, 1922500112, 20884521013244; 8888145044, 1925200063, 20884521013244; 8888145044, 1929500075, 20884521013244; 8888145044, 1929500092, 20884521013244; 8888145044, 1933700119, 20884521013244; 8888145044, 2000700104, 20884521013244; 8888145044, 2104600101, 20884521013244; 8888145044, 2104600102, 20884521013244; 8888145044, 2104900109, 20884521013244; 8888145044, 2106900137, 20884521013244; 8888145044, 2110900104, 20884521013244; 8888145044, 2113300436, 20884521013244; 8888145044, 2113400084, 20884521013244; 8888145044, 2116200115, 20884521013244; 8888145044, 2116200116, 20884521013244; 8888145044, 2116200117, 20884521013244; 8888145044, 2124500106, 20884521013244; 8888145044, 2124500121, 20884521013244; 8888145044, 2200300118, 20884521013244; 8888145045, 1929500093, 10884521017900; 8888145045, 1933700120, 10884521017900; 8888145045, 2004400084, 10884521017900; 8888145045, 2110900143, 10884521017900; 8888145045, 2113400059, 10884521017900; 8888145045, 1822000073, 20884521017907; 8888145045, 1929500093, 20884521017907; 8888145045, 1933700120, 20884521017907; 8888145045, 2004400084, 20884521017907; 8888145045, 2110900143, 20884521017907; 8888145045, 2113400059, 20884521017907; 8888145045, 2124500087, 20884521017907; 8888145046, 1927500059, 20884521013268; 8888145046, 1927500060, 20884521013268; 8888145069, 2017600095, 20884521056708; 8888145070, 2026000154, 20884521056715; 8888145043C, 1924600101, 10884521056305; 8888145043C, 1926100282, 10884521056305; 8888145043C, 2002900150, 10884521056305; 8888145043C, 2014900156, 10884521056305; 8888145043C, 2017500125, 10884521056305; 8888145043C, 2017500128, 10884521056305; 8888145043C, 2017600093, 10884521056305; 8888145043C, 2026000077, 10884521056305; 8888145043C, 2026000079, 10884521056305; 8888145043C, 2026000080, 10884521056305; 8888145043C, 2026000081, 10884521056305; 8888145043C, 2116200114, 10884521056305; 8888145043C, 2119400127, 10884521056305; 8888145043C, 2125800084, 10884521056305; 8888145043C, 2125800085, 10884521056305; 8888145043C, 2125800086, 10884521056305; 8888145043C, 2125800087, 10884521056305; 8888145043C, 1924600101, 20884521056302; 8888145043C, 1926100282, 20884521056302; 8888145043C, 2002900150, 20884521056302; 8888145043C, 2014900156, 20884521056302; 8888145043C, 2017500125, 20884521056302; 8888145043C, 2017500128, 20884521056302; 8888145043C, 2017600093, 20884521056302; 8888145043C, 2026000077, 20884521056302; 8888145043C, 2026000079, 20884521056302; 8888145043C, 2026000080, 20884521056302; 8888145043C, 2026000081, 20884521056302; 8888145043C, 2116200114, 20884521056302; 8888145043C, 2119400127, 20884521056302; 8888145043C, 2125800086, 20884521056302; 8888145043C, 2125800087, 20884521056302; 8888145043C, 2125800088, 20884521056302; 8888145044C, 1924600102, 10884521056312; 8888145044C, 1926100278, 10884521056312; 8888145044C, 1926100283, 10884521056312; 8888145044C, 1926100284, 10884521056312; 8888145044C, 1928100093, 10884521056312; 8888145044C, 2014900157, 10884521056312; 8888145044C, 2017600094, 10884521056312; 8888145044C, 2023300171, 10884521056312; 8888145044C, 2026000082, 10884521056312; 8888145044C, 2026000083, 10884521056312; 8888145044C, 2026000084, 10884521056312; 8888145044C, 2026000085, 10884521056312; 8888145044C, 2026000086, 10884521056312; 8888145044C, 2026000153, 10884521056312; 8888145044C, 2106900135, 10884521056312; 8888145044C, 2106900213, 10884521056312; 8888145044C, 2108100058, 10884521056312; 8888145044C, 1924600102, 20884521056319; 8888145044C, 1926100278, 20884521056319; 8888145044C, 1926100283, 20884521056319; 8888145044C, 1926100284, 20884521056319; 8888145044C, 1928100093, 20884521056319; 8888145044C, 2014900157, 20884521056319; 8888145044C, 2017600094, 20884521056319; 8888145044C, 2023300171, 20884521056319; 8888145044C, 2026000082, 20884521056319; 8888145044C, 2026000084, 20884521056319; 8888145044C, 2026000085, 20884521056319; 8888145044C, 2026000086, 20884521056319; 8888145044C, 2026000153, 20884521056319; 8888145044C, 2106900135, 20884521056319; 8888145044C, 2106900140, 20884521056319; 8888145044C, 2106900213, 20884521056319; 8888145044C, 2108100058, 20884521056319; 8888145044C, 2120000070, 20884521056319; 8888145045C, 1924600106, 10884521056329; 8888145045C, 1926100279, 10884521056329; 8888145045C, 1926800382, 10884521056329; 8888145045C, 1926800383, 10884521056329; 8888145045C, 2017500126, 10884521056329; 8888145045C, 2026000089, 10884521056329; 8888145045C, 1924600106, 20884521056326; 8888145045C, 1926100279, 20884521056326; 8888145045C, 1926800382, 20884521056326; 8888145045C, 1926800383, 20884521056326; 8888145045C, 2017500126, 20884521056326; 8888145045C, 2026000089, 20884521056326; 8888145045C, 2100500127, 20884521056326; 8888145046C, 2026000091, 10884521056336; 8888145046C, 2026000091, 20884521056333", "more_code_info": "" } ] }