Events

Recall of Device Recall Hospira Blood Set, with 200 Micron Filter

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
    60869
  • Event Risk Class
    Class 2
  • Event Number
    Z-0817-2012
  • Event Initiated Date
    2012-01-12
  • Event Date Posted
    2012-01-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106687
  • 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
    Silicone applied to the piercing pin of the blood set is reducing retention force of the piercing pin while in use. this could cause the piercing pin to slip out of the administration container.
  • Action
    The firm, Hospira, sent an "URGENT DEVICE RECALL" letter dated January 12, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory and immediately quarantine any affected product. Additionally, a Reply Form was attached for customers to complete and return via fax to 1-866-912-8410 or e-mail to: hospira2573@stericycle.com. Please contact Hospira Customer Care at 1-877-946-7747 for questions regarding this recall.

Device

Device Recall Hospira Blood Set, with 200 Micron Filter
  • Model / Serial
    list 14203-28, lot 96-146-5H
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of North Carolina and Washington.
  • Product Description
    Hospira Blood Set, with 200 Micron Filter, 80 Inch, Non-DEHP; an Rx sterile medical device used to administer blood products; 48 individually wrapped sets per case; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 USA; list 14203-28. || Intended use: for the administration of blood products.
  • 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