Events

Recall of LifeShield Primary Plumset

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
    61680
  • Event Risk Class
    Class 2
  • Event Number
    Z-1491-2012
  • Event Initiated Date
    2012-04-25
  • Event Date Posted
    2012-05-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108703
  • 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 lifeshield primary plumsets may cause a cassette test failure alarm when the set is loaded onto the infusion pump. a set which results in a cassette test failure alarm may result in delay in therapy, requiring medical intervention.
  • Action
    Hospira, sent an "URGENT DEVICE RECALL" letter dated April 25, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The customers were instructed to check their inventory and immediately quarantine any affected product to return for credit. A Reply Form was enclosed for customers to complete and return via fax to 1-888-386-2073 or e-mail to: Hospira8503@stericycle.com. Contact Hospira Customer Care at 1-877-946-7747 for information regarding product availability.

Device

LifeShield Primary Plumset
  • Model / Serial
    list number 12030-12; lot number 89-029-5H; expiration date 01 JUN 2013
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of: Alabama, Colorado, Georgia, Illinois, Indiana, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Oklahoma, Pennsylvania, Wisconsin and the country of Australia.
  • Product Description
    LifeShield Primary Plumset, CLAVE port, CLAVE Y-Site, 104 inch, 15 drops/mL, 48 sets per case; a sterile Rx device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 120300412, list number 12030-12. || Product Usage: For administration of I.V. fluids.
  • 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