Events

Recall of Transfer/Gait Belt

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
    78363
  • Event Risk Class
    Class 2
  • Event Number
    Z-0164-2018
  • Event Initiated Date
    2017-08-10
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159346
  • 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
    Aid, transfer - Product Code IKX
  • Reason
    The locking mechanism on the belt may fail to secure/hold the strap when in locked position potentially allowing the belt strap to slip through the buckle.
  • Action
    Medline Industries sent an Immediate Action Required Recall Notification letter via First Class mail dated August 10, 2017. The recall was later expanded and customers were notified via letter of the additional lots dated August 21, 2017. Instructions in both letters included to check inventory and quarantine any affected product, complete and return the included response form, coordinate the return of all affected product, and notify customers if the product was further distributed. Additional customers were identified and notified of the recall via the same process on September 19th, 2017. For further questions, please call (866) 359-1704.

Device

Transfer/Gait Belt
  • Model / Serial
    Model No. MDT821203WPL, all lot numbers that begin with 90317XXXXXX. "X" represents any number.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA (nationwide) Distribution to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NV, NY, OH , OK, OR, PA, RI, SC, TN, TX, VA, VT, WA, WI and WV.
  • Product Description
    Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box.
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • Manufacturer Address
    Medline Industries Inc, Three Lakes Drive, Northfield IL 60093
  • Manufacturer Parent Company (2017)
    Medline Industries Inc.
  • Source
    USFDA