Events

Recall of Cardinal Health Presource PBDS Convenience Kits

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
    33767
  • Event Risk Class
    Class 2
  • Event Number
    Z-0164-06
  • Event Initiated Date
    2005-10-03
  • Event Date Posted
    2005-11-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42684
  • 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 procedure kits labeled as latex-free may contain a 4' or 6' ultra-weave premium elastic bandage containing dry, natural rubber latex.
  • Action
    Cardinal Health notified the accounts who ordered the affected packs via letter dated 10/3/05, informing them that the packs that were labeled latex-free actually contained an elastic bandage that contained latex rubber. The letters were accompanied by a listing of catalog numbers and work order numbers for the affected packs ordered by each account. The accounts were requested to telephone Cardinal Customer Service at 1-800-964-5227 for return instructions for the affected packs return to Cardinal Health for replacement.

Device

Cardinal Health Presource PBDS Convenience Kits
  • Model / Serial
    Cat. PO23AAMCC, order numbers 641370 and 655171; Cat. PO23TKMCC, order numbers 637245 and 639306;  Cat. SOP11OPFGB, order numbers 640349, 641634, 644009, 651563 and 653696;  Cat. SCV48CVJHD, order numbers 722851 and 728463.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    South Carolina, New York, Nebraska, Florida and internationally to Canada
  • Product Description
    Cardinal Health Presource PBDS Latex Free Convenience Kits; sterile single use disposable devices packaged in plastic pouches; Cardinal Health, McGaw Park, IL 60085 U.S.A.; identified by the following catalog numbers: || a) Cat. PO23AAMCC - Arthroscopy Kit || b) Cat. PO23TKMCC - Total Knee Kit || c) Cat. SOP11OPFGB - Ortho Pack || d) Cat. SCV48CVJHD - Strl Open Heart Part A & B Pk
  • Manufacturer
    Cardinal Health

Manufacturer

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