BEUDAMED
    FDA Enforcement Class II Ongoing

    Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin Coating and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, apheresis, and infusion. Model Number (CFN): 8888145044CP

    Recall: Z-1635-2024 · Reported May 1, 2024

    Enforcement

    Recall Number
    Z-1635-2024
    Event ID
    94266
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Covidien LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 1, 2024
    Initiation Date
    March 15, 2024
    Classification Date
    April 24, 2024
    Address
    15 Hampshire St, N/A, Mansfield, MA, 02048-1113, United States

    Description

    Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin Coating and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, apheresis, and infusion. Model Number (CFN): 8888145044CP

    Reason

    Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating

    Code Info

    GTIN: 20884521158082, 10884521158085 Lot Number: 2228000089, 2201700103, 2228000074

    Distribution

    Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Denmark, Faroe Islands, France, Germany, Greece, Iceland, Ireland, Italy, Mayotte, Norway, Poland, Reunion, South Africa, Spain, Sweden, United Kingdom.

    Quantity

    878 units