Events

Recall of Device Recall Convertors Robotic Drape with Attached Leggings; Product is packaged as Single Sterile Drape

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cardinal Health 200, LLC.

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
    77917
  • Event Risk Class
    Class 2
  • Event Number
    Z-3046-2017
  • Event Initiated Date
    2017-07-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158213
  • 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
    Sudan iv - Product Code KKK
  • Reason
    Product 29474 lavh drape was packaged as 29574 robotic drape with leggings.
  • Action
    Cardinal Health sent an Urgent: Product Recall letter dated July 28, 2017. Distributors are requested to notify their customers of the action. An acknowledgement form is included as part of the notification. Responses are tracked. All returned product will be quarantined. All inventory recovered from the field will be destroyed. For further questions, please call (800) 292-9332.

Device

Device Recall Convertors Robotic Drape with Attached Leggings; Product is packaged as Single Ste...
  • Model / Serial
    Lot number 17DAH349
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : NC, UT, OR, NY,TX, GA, NJ and FL.
  • Product Description
    Convertors Robotic Drape with Attached Leggings; Product is packaged as Single Sterile Drape/8 per Case
  • Manufacturer
    Cardinal Health 200, LLC

Manufacturer

Cardinal Health 200, LLC
  • Manufacturer Address
    Cardinal Health 200, LLC, 1500 S Waukegan Rd, Waukegan IL 60085-6728
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    USFDA