Palindrome H Chronic Catheter recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product

Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.

Recalling firm

Covidien Llc

Quantity

26,474 units

Distribution

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 date

July 13, 2022

Classification

Class I

Status

Ongoing

Agency

FDA (device)