Events

Recall of YType Blood Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hospira Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65689
  • Event Risk Class
    Class 1
  • Event Number
    Z-1857-2013
  • Event Initiated Date
    2013-04-01
  • Event Date Posted
    2013-08-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119890
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Extra notes in the data
    Set, blood transfusion - Product Code BRZ
  • 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 ProductComplaintsPP@hospira.com. 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.

Device

YType Blood Set
  • Model / Serial
    List Number: 14217-28;  Lot Number: 962255H
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.
  • Product 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
  • Manufacturer
    Hospira Inc.

Manufacturer

Hospira Inc.
  • Manufacturer Address
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    USFDA