Events

Recall of Device Recall LifeShield Primary SYMBIQ Set

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
    54195
  • Event Risk Class
    Class 2
  • Event Number
    Z-0808-2010
  • Event Initiated Date
    2010-01-08
  • Event Date Posted
    2010-02-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87806
  • 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
    Set, administration, intravascular - Product Code FPA
  • Reason
    There is a potential for fluid to leak from the backcheck valve which could result in inaccurate delivery and occupational exposure.
  • Action
    Hospira Medical issued an "Urgent Device Recall" notification dated January 8, 2010 informing consignees of the affected product. The accounts were instructed to examine their inventory and quarantine affected product immediately and arrange for its return. Users were also requested to complete the enclosed reply form and return it to the firm. For further information, contact Hospira Medical Communications at 1-800-615-0187.

Device

Device Recall LifeShield Primary SYMBIQ Set
  • Model / Serial
    List Number: 16096-28, Lot: 82-028-5H
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Minnesota and Utah
  • Product Description
    LifeShield Latex-Free Primary SYMBIQ Set, Piggyback with Backcheck Valve, 3 Prepierced Y-Sites, 106 inch, Non-DEHP, 15 drops/mL; an Rx sterile single use fluid path way for administration of I.V. fluids using the Symbiq infusion pump; 48 sets per case; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list number 16096-28.
  • Manufacturer
    Hospira Inc.

Manufacturer

Hospira Inc.
  • Manufacturer Address
    Hospira Inc., 375 N Field Dr, Lake Forest IL 60045-2513
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    USFDA