BEUDAMED
    FDA Recall Terminated

    List No. 14219-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, CLAVE 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-1858-2013 · Initiated April 1, 2013

    Recall

    Recall Number
    Z-1858-2013
    Event Number
    65689
    Firm
    Hospira Inc.
    FEI Number
    3013319212
    Product Code
    BRZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 1, 2013
    Posted
    August 5, 2013
    Terminated
    May 24, 2017
    Address
    275 N Field Dr, Lake Forest, IL, 60045-2579

    Description

    List No. 14219-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, CLAVE 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.

    Action

    Hospira sent an Important Safety Information letter dated April 1, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to exercise EXTREME CAUTION when using Hospira blood bags and to make sure that all instructions for use are included with the blood bag and their facility's protocol for spiking blood bags are completely followed in order to minimize the possibility of puncturing the outer wall of the blood bag. Customers with issues were instructed to call Hospira at 1-800-441-4100 or email [email protected]. Customers were asked to complete the attached replay formand return it to the fax number on the form. If customers distributed the product further they were instructed to notify their accounts that received the affected product and ask them to contact Stericycle at 1-866-608-3936 to receive a reply form. Customers with questions were instructed to contact Hospira at 1-800-441-4100. For questions regarding this recall call 224-212-2000.

    Distribution

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

    Quantity

    3,600 units