Events

Recall of Device Recall Custom Sterile

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
    26609
  • Event Risk Class
    Class 2
  • Event Number
    Z-1023-03
  • Event Initiated Date
    2003-06-27
  • Event Date Posted
    2003-07-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-09-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28498
  • 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
    General Surgery Tray - Product Code LRO
  • Reason
    The kits labeled as sterile were stolen in transit to the sterilizer and have not been sterilized.
  • Action
    The customers who ordered the custom packs were notified of the theft of the unsterilized packs via letter dated 6/27/03, sent via Airborne Express. The accounts were requested to inspect their inventory for the affected catalog numbers and order/lot numbers, and segregate any of the product found for return and replacement.

Device

Device Recall Custom Sterile
  • Model / Serial
    Catalog SBA61MJSFH, Sterile Laparotomy Pack, Mfg date 5/21/03, order 101438;
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    New Jersey, Tennessee, Missouri and Minnesota
  • Product Description
    Catalog SBA61MJSFH, Sterile Laparotomy Pack, Mfg date 5/21/03, order 101438;
  • Manufacturer
    Cardinal Health

Manufacturer

Cardinal Health
  • Manufacturer Address
    Cardinal Health, 1500 Waukegan Rd, Bldg K, Mcgaw Park IL 60085-6787
  • Source
    USFDA