BEUDAMED
    FDA Enforcement Class I Terminated

    List No. 14217-28; Y-TYPE BLOOD SET; 200 Micron Filter, Prepierced Y-Site, Non-Vented, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration

    Recall: Z-1857-2013 · Reported August 14, 2013

    Enforcement

    Recall Number
    Z-1857-2013
    Event ID
    65689
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hospira Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 14, 2013
    Initiation Date
    April 1, 2013
    Classification Date
    August 5, 2013
    Termination Date
    May 24, 2017
    Address
    275 N Field Dr, N/A, Lake Forest, IL, 60045-2579, United States

    Description

    List No. 14217-28; Y-TYPE BLOOD SET; 200 Micron Filter, Prepierced Y-Site, Non-Vented, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration

    Reason

    It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.

    Code Info

    List Number: 14217-28; Lot Number: 962255H

    Distribution

    Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.

    Quantity

    1,104 units