Events

Recall of Device Recall LifeCare PCA3

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
    34053
  • Event Risk Class
    Class 2
  • Event Number
    Z-0601-06
  • Event Initiated Date
    2005-11-02
  • Event Date Posted
    2006-03-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-08-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43018
  • 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
    Pump, Infusion, Pca - Product Code MEA
  • Reason
    Incorrect values for dosage, dose limit, concentration or rate of delivery may display on screen.
  • Action
    Field corrections initiated November 2, 2005. The firm has sent notification letters to consignees via Federal Express.

Device

Device Recall LifeCare PCA3
  • Model / Serial
    List numbers 12384-04, software version 4.08 and 4.09
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. Distributed to 544 domestic consignees, all direct users.
  • Product Description
    Hospira LifeCare PCA3 Infusion System Software, versions 4.08 and 4.09
  • Manufacturer
    Hospira Inc

Manufacturer

Hospira Inc
  • Manufacturer Address
    Hospira Inc, 755 Jarvis Dr, Morgan Hill CA 95037-2810
  • Source
    USFDA