BEUDAMED
    FDA Enforcement Class I Ongoing

    Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.

    Recall: Z-1314-2022 · Reported July 13, 2022

    Enforcement

    Recall Number
    Z-1314-2022
    Event ID
    90311
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Covidien Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 13, 2022
    Initiation Date
    June 8, 2022
    Classification Date
    July 7, 2022
    Address
    15 Hampshire St, N/A, Mansfield, MA, 02048-1113, United States

    Description

    Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.

    Reason

    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.

    Code Info

    Code Information organized as "Model No., Serial No., GTIN": 8888119368, 1925200090, 20884521012841; 8888119368, 1933700094, 20884521012841; 8888119368, 2001400077, 20884521012841; 8888119368, 2026000056, 20884521012841; 8888123408, 2009400114, 20884521012957; 8888128458, 1935100068, 20884521013039; 8888133508, 2026000060, 20884521013107; 8888145062, 2031800153, 10884521013407; 8888145062, 1933700095, 20884521013404; 8888145062, 2009400116, 20884521013404; 8888145062, 2031800131, 20884521013404; 8888145062, 2031800153, 20884521013404; 8888145063, 2000700056, 20884521013428; 8888145063, 2009400113, 20884521013428; 8888145063, 2027200181, 20884521013428; 8888145064, 2030100077, 20884521013442; 8888145065, 2026000067, 20884521013466; 8888145066, 2011900104, 10884521013476; 8888145066, 2019500162, 10884521013476; 8888145066, 2011900104, 20884521013473; 8888145066, 2019500162, 20884521013473

    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.

    Quantity

    2,462 units