Events

Recall of Device Recall LifeShield Symbiq Pump 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
    54080
  • Event Risk Class
    Class 2
  • Event Number
    Z-1051-2010
  • Event Initiated Date
    2009-11-24
  • Event Date Posted
    2010-03-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87381
  • 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
    Company has confirmed reports of backflow of fluid past the backcheck valve on symbiq administration sets.
  • Action
    Hospira, Inc. issued an "Important Administration Set Information" letter dated November 24, 2009 to their direct accounts, informing them of the affected product. Consignees were instructed to return the defective product to the firm. For further information, contact Hospira Medical Communications at 1-800-615-0187.

Device

Device Recall LifeShield Symbiq Pump Set
  • Model / Serial
    Lot numbers: 601365H, 631865H, 641595H, 661005H, 661965H, 662025H, 671815H, 671825H, and 671835H.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Australia, Canada, Costa Rica, India, Mexico, Netherlands, Philippines, Singapore and United Arab Emirates.
  • Product Description
    Latex-Free Symbiq Pump Set, convertible pin, 106 inch, piggyback with backcheck valve, 3 prepierced injection sites, and OPTION-LOK, non-DEHP, 15 drops/mL; a sterile Rx device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 160380428, list number 16038-28.
  • 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