Recall of Device Recall Minibore Extension 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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Tubing, fluid delivery - Product Code FPK
  • Reason
    Hospira, inc. is voluntarily recalling one lot of list 14699-28, minibore extension set, 59 inch with spin lock collar, non-dehp, identified above due to a confirmed customer report of an occlusion of solvent in the male luer lock. this occlusion has the potential to prevent the set from being primed for use and cause a delay in therapy.
  • Action
    Hospira sent an Urgent Device Recall letter dated February 19, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please check your inventory and immediately quarantine any affected product. Complete the attached reply form and return it to the fax number or e-mail address on the form, even if you do not have the affected product. Inform healthcare professionals in your organization of this recall. Return affected product to Stericycle using the label provided with this letter. If you have not received a return label or require additional assistance contact Stericycle at 1-888-965-5821 between the hours of Bam to 5pm EST, Monday through Friday. To ensure proper and timely credit, follow the instructions on the return label for returning the product. Please visit to request additional labels for returning affected product. If you have distributed the product further, notify your accounts that received the product identified above of this recall and ask them to contact Stericycle to receive a reply form and return labels for returning the product. Please contact Hospira Customer Care at 1-877-946-7747, between the hours of 6am to 6pm CST, Monday through Friday, or your Hospira representative regarding replacement product availability. For further questions please call (224) 212-2000.


  • Model / Serial
    Product List Number: 14699-28;  Lot Number: 17-077-NS
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide Distribution
  • Product Description
    Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free || Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
  • Manufacturer


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