Events

Recall of Device Recall Hospira Latex Free Blood Secondary 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
    34354
  • Event Risk Class
    Class 2
  • Event Number
    Z-0504-06
  • Event Initiated Date
    2006-01-09
  • Event Date Posted
    2006-02-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43608
  • 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
    The i.V. administrations sets were stolen in-transit between the manufacturing site and the sterilizer, resulting in non-sterilized product possibly being on the market.
  • Action
    Hospira notified all of their customers who purchased these list numbers within the last year via letter dated 1/9/06, informing them of the diversion of the affected lots of product prior to being sterilized and that use of the lots could result in the delivery of fluids through a non-sterile pathway. They requested the accounts to check their stocks of the affected list numbers for the list lot numbers. If any of the lots are found in stock, they were requested to place them in quarantine immediately and call Hospira Customer Care at 1-877-946-7747.

Device

Device Recall Hospira Latex Free Blood Secondary Set
  • Model / Serial
    list 4602-58, lot 35-092-5H
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The lots were not released or distributed by Hospira
  • Product Description
    Hospira Latex Free Blood Secondary Set, 26 inch with Secure Lock; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 U.S.A.
  • 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