Events

Recall of Device Recall Empty Evacuated Container 250 mL and 1000 mL.

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
    63078
  • Event Risk Class
    Class 2
  • Event Number
    Z-2395-2012
  • Event Initiated Date
    2012-08-28
  • Event Date Posted
    2012-09-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112479
  • 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
    Container, i.V. - Product Code KPE
  • Reason
    Embedded iron oxide glass defect which may have the potential to break off into the solution.
  • Action
    Hospira sent an "URGENT DEVICE RECALL" dated August 28, 2012 to all affected customers. The letter identified the product, problem,and actions to be taken by the customers. The letter included an Urgent Device Recall Reply Form for customers to complete and return via fax to 1-888-237-5582. Contact Hospira Customer Care at 1-877-946-7747 for questions regarding this recall.

Device

Device Recall Empty Evacuated Container 250 mL and 1000 mL.
  • Model / Serial
    250 mL size - Lot 11179DW, Exp, Date 1NOV2013, 11195DW, Exp. Date 1NOV2013 and 93854DW, Exp. Date 1SEP2012 - 1000 mL size - Lot 92835DW, Exp. Date 1AUG2012, Lot 96090DW, Exp. Date 1DEC2012, and Lot 96098DW, Exp. Date 1DEC2012
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Saudi Arabia, Canada and Barbados.
  • Product Description
    Empty Evacuated Container 250 mL and 1000 mL. || Empty Evacuated containers are used for mixing compatible medications or blood collections.
  • 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