Events

Recall of Cardinal Health Custom Sterlie 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-0163-06
  • 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=42412
  • 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 Custom Sterlie Convenience Kits
  • Model / Serial
    Cat. POOCOTFGB, order numbers 9904815, 9911445, 9911446, 9923559, 9926928, 9929035 and 9932551; Cat.SOP22ARCLC, order number 144191;  Cat. SOP30ARCOB, order number 704460;  Cat. SOP30ARCOC, order numbers 713043 and 717623;  Cat. SOP30ARKGC, order number 716550;  Cat. SOP30ARMCB, order numbers 708643 and 717298;  Cat. SOP30ARNOA, order number 728554;  Cat. SOP30KANRA, order number 708579;  Cat. SOP30LENHC, order numbers 702865 and 714615;  Cat. SOP30SADTE, order number 717371;  Cat. SOP30THDTD, order number 715392;  Cat. SOP30THNOA, order number 728333;  Cat. SOP30THSJA, order number 710742;  Cat. SOP30TKSJA, order number 709389;  Cat. SOP30THVCH, order numbers 709885 and 719564;  Cat. SOP30TKVCE, order numbers 703408 and 716341
  • 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 Custom Sterile 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. POOCOTFGB - Sterile Ortho Pack || b) Cat.SOP22ARCLC - Sterile Arthoscopy Pack || c) Cat. SOP30ARCOB - Sterile Knee Arthroscopy Pack || d) Cat. SOP30ARCOC - Sterile Knee Arthroscopy Pack || e) Cat. SOP30ARKGC - Sterile Arthroscopy Pk || f) Cat. SOP30ARMCB - Sterile McCallum Surgical Pack || g) Cat. SOP30ARNOA - Sterile Arthroscopy Pack || h) Cat. SOP30KANRA - Sterile Knee Arthroscopy Pack || i) Cat. SOP30LENHC - Strl Major Lower Extremity Pk || j) Cat. SOP30SADTE - Strl Shoulder Arthroscopy Pack || k) Cat. SOP30THDTD - Sterile Total Hip Pack || l) Cat. SOP30THNOA - Sterile Total Hip Pk || m) Cat. SOP30THSJA - Sterile Total Hip Pack || n) Cat. SOP30TKSJA - Sterile Total Knee Pack || o) Cat. SOP30THVCH - Sterile Total Hip Pack || p) Cat. SOP30TKVCE - Sterile Total Knee Pack
  • Manufacturer
    Cardinal Health

Manufacturer

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