Events

Recall of Device Recall Hospira LifeShield LatexFree YType Blood Set, 100 Inch

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
    58276
  • Event Risk Class
    Class 2
  • Event Number
    Z-2025-2011
  • Event Initiated Date
    2011-03-28
  • Event Date Posted
    2011-04-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98894
  • 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
    Instrument, surgical, disposable - Product Code KDC
  • Reason
    There is a potential for the air filter at the distal end of the set to become detached. this could result in the contamination of the sterile fluid path inside the tubing.
  • Action
    The firm, Hospira, sent an "URGENT DEVICE RECALL" letter dated March 28, 2011 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to check their inventory and immediately quarantine any affected product; complete and return the Reply Form via fax to 1-866-324-3734, even if you do not have the affected product; inform healthcare professionals in their organization of this recall; if they have distributed the product further, notify their accounts and have them fax the reply form to 1-866-324-3724; return the affected product to Stericycle using labels provided, and call Stericycle at 1-877-877-0481, if they have not received a return label. For medical inquiries, please call Hospira Medical Communications at 1-800-615-0187. Call Hospira Global Product Safety and Complaints at 1-800-441-4100 (8am-5pm CST, M-F) or by e-mail at (ProductComplaintsPP@hospira.com).

Device

Device Recall Hospira LifeShield LatexFree YType Blood Set, 100 Inch
  • Model / Serial
    List No. 12450-48, lots 930875H and 940445H
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries including: Canada, Korea and Singapore.
  • Product Description
    Hospira LifeShield Latex-Free HEMA Y-Type Blood Set, Nonvented, 100 Inch with Clave and Secure Lock; a sterile Rx tubing set for the alternate administration of fluids from a blood bag and I.V. solution container; Made in Costa Rica; Hospira, Inc., Lake Forest, IL 60045 USA; List No. 12450-48 || For the alternate administration of fluids from a blood bag and I.V. solution container
  • 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