Events

Recall of Syrex

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Excelsior Medical Corp.

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
    35960
  • Event Risk Class
    Class 2
  • Event Number
    Z-0044-2007
  • Event Initiated Date
    2006-04-24
  • Event Date Posted
    2006-10-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-10-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47264
  • 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.
  • Extra notes in the data
    syringe - Product Code NGT
  • Reason
    The syringe manufacturer mixed a pre-printed heparin labeled flush syringe with the saline syringes.
  • Action
    Excelsior notified Hospira of the recall on 4/24/2006. Hospira notified Morris Dickson and Cardinal Health on 4/28/2006.

Device

Syrex
  • Model / Serial
    Product E0100-30, Lot 22-010-9D
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide.
  • Product Description
    0.9% Sodium Chloride Flush Syringe, 2.5 mL. Product Code: E0100-30. Manufactured by Excelsior Medical and distributed by Hospira, Lake Forest, IL under Hospira''s label, Syrex.
  • Manufacturer
    Excelsior Medical Corp

Manufacturer

Excelsior Medical Corp
  • Manufacturer Address
    Excelsior Medical Corp, 1923 Heck Ave, Neptune NJ 07753-4428
  • Source
    USFDA