Events

Recall of Device Recall Angiographic Syringe

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
    30478
  • Event Risk Class
    Class 2
  • Event Number
    Z-0618-05
  • Event Initiated Date
    2004-11-02
  • Event Date Posted
    2005-03-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35973
  • 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
    Catheter, Intravascular, Diagnostic - Product Code DQO
  • Reason
    Syringes could possibly allow air to enter the patient's vascular system.
  • Action
    Consignees were notified by letter on 11/10/04 or by telephone on 11/11/04.

Device

Device Recall Angiographic Syringe
  • Model / Serial
    List Numbers: 4204201 Lot Numbers: 13193SN; 15171SN; 17151SN
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Domestic distribution: Nationwide, including 2 military/VA facilities. International distribution: Spain, Belgium, Greece, Japan, and France.
  • Product Description
    Angiographic Syringe, 12 cc Thumb Ring with Rotator Reservoir.
  • 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