Events

Recall of Device Recall Hospira

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
    32077
  • Event Risk Class
    Class 2
  • Event Number
    Z-0389-06
  • Event Initiated Date
    2005-05-18
  • Event Date Posted
    2006-01-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39084
  • 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 - Product Code FRN
  • Reason
    The pump may shut-off prematurely during battery operation without providing adequate response time when 'e320' service warning message appears.
  • Action
    On 5/18/05, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected products and providing instructions on the recall.

Device

Device Recall Hospira
  • Model / Serial
    List No. 11971-04 Plum A+ I.V. Infusion Pump; List No. 12391-04 Plum A+ I.V. Infusion Pump;  List No. 12618-04 Plum A+3 I.V. Infusion Pump;  List No. 12348-04 Plum A+3 I.V. Infusion Pump.  List Numbers: 12618-04; List Numbers: 11971-36; (shipped 12391-04; (shipped 11971-04; domestically) 11971-04; internationally) 12391-04;  12348-04; 12348-04;  12391-13; 12391-1312391-1   12618-04. All serial numbers of the above list numbered product are included in this correction.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed nationwide to 746 domestic consignees. Product was distributed internationally to the following countries: Puerto Rico, Canada, Saudi Arabia, Taiwan, Australia, Italy, Jordan, New Zealand, Spain, Turkey, and United Arab Emirates.
  • Product Description
    Hospira brand Plum A+I.V. Infusion Pump, List No. 11971-04; || Hospira brand Plum A+I.V. Infusion Pump, List No. 12391-04; || Hospira brand Plum A+3 I.V. Infusion Pump, List No. 12618-04; || Hospira brand Plum A+3 I.V. Infusion Pump, List No. 12348-04; || Infusion pump is a multi-function fluid delivery infusion system, consisting of pumping module and assortment of IV sets. || Product is manufactured and distributed by || Hospira Inc., 755 Jarvis Dr., Morgan Hill, CA
  • Manufacturer
    Hospira Inc

Manufacturer

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