Events

Recall of Device Recall Custom Sterile Cardiac Cath Pack

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

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
    27757
  • Event Risk Class
    Class 2
  • Event Number
    Z-0266-04
  • Event Initiated Date
    2003-11-15
  • Event Date Posted
    2003-12-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-10-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30475
  • 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
    unknown device name - Product Code HAP
  • Reason
    The namic angiography kit attached to the outside top of the custom sterile pack is not sterile.
  • Action
    Recalled by salesman visit on 11/15/03 and follow-up faxed letter dated 11/18/03. The hospital was instructed to inspect their inventory for the affected catalog number and work order numbers, segregating them and placing the provided warning labels on the pack. The warnijng labels instruct the user not to use the Namic Angiography Kit attached to the pack and return the kit to Cardinal Health.

Device

Device Recall Custom Sterile Cardiac Cath Pack
  • Model / Serial
    catalog number SAN25CCEAQ, lot numbers 548727, 548723, 544906, 542967, 542966
  • Distribution
    Georgia, Alabama
  • Product Description
    Custom Sterile Cardiac Cath Pack, catalog SAN25CCEAQ, Cardinal Health, McGaw Park, IL 60085 USA
  • Manufacturer
    Cardinal Health

Manufacturer

Cardinal Health
  • Manufacturer Address
    Cardinal Health, 1430 Waukegan Rd, McGaw Park IL 60085
  • Source
    USFDA