Events

Recall of Device Recall Medline Angio Drape Pack RadiologyLF

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

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
    63739
  • Event Risk Class
    Class 2
  • Event Number
    Z-0568-2013
  • Event Initiated Date
    2012-11-08
  • Event Date Posted
    2012-12-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114684
  • 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 (kit) - Product Code LRO
  • Reason
    The non-sterile waste bag component in the custom pack was attached to the outside of the pack in its own packaging. the product was not labeled or identified as sterile, but was assumed to be sterile by the customer.
  • Action
    The firm, Medline Industries, Inc., telephoned the consignee/customer on November 8, 2012. The phone call informed the customer of the product, problem and actions to be taken. The customer was instructed to inform the staff at the facility not to use the pack until it had been reworked to replace the non-sterile waste bag with the sterile equivalent. It was also noted that the product does not need to be returned as it is being replaced directly at the facility. If you have any question call 847-837-2759 or email lsimmons@medline.com.

Device

Device Recall Medline Angio Drape Pack RadiologyLF
  • Model / Serial
    Reorder #DYNJ35993D, lot numbers 12HD2126, exp. 5/31/2015; 12IB5014, exp. 7/31/2015 and 12JB8311, exp. 5/31/2015
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: New York only.
  • Product Description
    Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescription procedure pack, including a waste bag, for use by the Interventional Radiology Department; Packaged for Medline Industries, Inc.; Reorder #DYNJ35993D || This custom pack includes components necessary for a specific procedure.
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • Manufacturer Address
    Medline Industries Inc, 1 Medline Pl, Mundelein IL 60060
  • Manufacturer Parent Company (2017)
    Medline Industries Inc.
  • Source
    USFDA