Events

Recall of Hospira Plum A I.V. infusion pump

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
    29982
  • Event Risk Class
    Class 2
  • Event Number
    Z-0438-05
  • Event Initiated Date
    2004-09-08
  • Event Date Posted
    2005-01-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-09-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34906
  • 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
    Ph Rate Measurement, Carbon-Dioxide - Product Code JFL
  • Reason
    The batteries in plum a+ and plum a+3 i.V. infusion pumps may fail prematurely when the pump is operating solely on battery power.
  • Action
    On 9/8/04, all consignees were notified via written letter sent via Federal Express, informing them of the affected products and providing instructions on the recall. The firm will follow up with phone calls to its consignees.

Device

Hospira Plum A I.V. infusion pump
  • Model / Serial
    The following LIST numbers are under recall. All lots (serial numbers) are currently under recall. LIST No. 11971-04 and LIST No. 12391-04.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The firm distributed these products to 484 consignees throughout the US, and an undetermined number of foreign consignees. The firm has distributed the product nationwide, excluding AK, HI, NV, NM, SC, and SD. The firm has sent products to Veterans Supply Office Pharmacy, Dept. of Veteran''s Affairs, Vet Admin Medical Center and US Pentitentiary-MC. Foreign countries that have received the product incluide Saudi Arabia, Canada, Puerto Rico and Taiwan.
  • Product Description
    The Hospira Plum A+ I.V. Infusion pump is a cassette-based, multi-function fluid delivery infusion system, consisting of pumping module and assortment of IV sets.
  • Manufacturer
    Hospira Inc

Manufacturer

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