Events

Recall of LifeShield LatexFree HEMA YType Blood Set IV Administration 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
    67038
  • Event Risk Class
    Class 2
  • Event Number
    Z-1126-2014
  • Event Initiated Date
    2013-10-25
  • Event Date Posted
    2014-03-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124587
  • 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, administration, intravascular - Product Code FPA
  • Reason
    Several lots of the lifeshield latex-free hema y-type blood set iv administration set were assembled incorrectly.
  • Action
    The firm, Hospira, sent "URGENT MEDICAL DEVICE CORRECTION" letters dated October 25, 2013 to all direct accounts/customers.The letter described the product, problem and actions to be taken. The letters instructed customers to: discontinue use of the recalled product lots; search storage areas, supply carts, and other patient care areas for affected lots and to remove any discovered recalled products; quarantine all recalled products; complete and return the attached RESPONSE REQUIRED form via fax at 1-888-356-6430 or e-mail to: Hospira6107@stericycle.com; return affected products using the labels supplied with the letter; if you have not received a return label or reply form or require additional assistance; and, if the recalled products were further distributed, to forward the recall information to them and have them call Stericycle at 866-229-7775 (Monday - Friday, 8:00 AM - 5:00 PM EST) to receive a reply form. The letter further instructs customers to ensure that the facility's protocol(s) for administering fluids and blood products are followed and to report any backflow, inability or difficulty priming, or no flow issues to Hospira at 800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM CST) or via e-mail at ProductComplaintsPP@hospira.com. For further inquiries, please contact Hospira using the information provided: Reports of adverse events or product complaints can be made by contacting Hospira Global Complaint Management at 800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM CST) of via e-mail at ProductComplaintsPP@hospira.com. General medical inquiries can be made by contacting Hospira Medical Communications at 800-615-0187 (24 hours a day, 7 days a week) or via e-mail at medcom@hospira.com. This information was also posted to Hospira's Internet website.

Device

LifeShield LatexFree HEMA YType Blood Set IV Administration Set
  • Model / Serial
    *** 1) List number 126970465; Lot Numbers: 281145H, 180015H, 040115H, 8804085H, 782245H, 680585H;   *** 2) List Number 127200465; Lot Numbers: 161475H, 153405H, 031595H;   *** 3) List Number 046419701: Lot Numbers: 040945G, 131335G
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including states of: AL, AR, AZ, CA, FL, GA, IL, IN, KS, KY, LA, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, TN, TX, VA, WI, WV and Puerto Rico; and countries of Canada, Espana, France, Ireland, and Slovenia.
  • Product Description
    *** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA; Y-TYPE BLOOD SET, Nonvented, 88 Inch with 210 Micron Filter Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira, Inc., Lake Forest, IL 60045 USA; || *** 2) List Number 127200465 labeled in part: 12720-65 LifeShield LATEX-FREE HEMA; BLOOD SET, Nonvented, 81 Inch with 170 Micron Filter, Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira, Inc., Lake Forest, IL 60045 USA; || *** 3) List Number 046419701 labeled in part: Hospira VENISYSTEMS Blood Bottle Pump Set with CAIR Clamp || Hospira infusion blood sets are intended for the delivery of fluids, including but not limited to, blood and blood products, from a container to a patient's vascular system.
  • 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