Events

Recall of Device Recall Blue Belt Technologies

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Blue Belt Technologies MN.

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
    65834
  • Event Risk Class
    Class 2
  • Event Number
    Z-1995-2013
  • Event Initiated Date
    2013-07-19
  • Event Date Posted
    2013-08-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120387
  • 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
    Drape, surgical - Product Code KKX
  • Reason
    Blue belt technologies is recalling sterile monitor drapes used with their navio pfs system during orthopedic knee surgery. the drapes are used to cover the navio pfs system computer monitor and arm assembly and provide a sterile barrier in the surgical suite. the defect is evident when the computer monitor is being draped. the front section of the drape separates from the rest of the drape at.
  • Action
    Blue Belt Technologies contacted consignees by telephone using a script on July 19, 2013. The consignees were informed of the problem and the product involved in the recall. Consignees were advised to immediate stop using the product and to locate and quarantine all unused product. Additionally, an "Urgent Medical Device Recall" letter dated July 24, 2013 was issued on July 24, 2013 and August 12, 2013. The letter includes the description of the Issue, description of safety concerns, affected product, and action to be taken by user. For questions contact Blue Belt Technologies, Lindsey Bring (+1 763.452.4922) or Robin Gonzalez (+1 763.452.4910) and get a Return Authorization number. Lindsey or Robin will arrange a pickup of the product. BBT will send replacement product at no charge.

Device

Device Recall Blue Belt Technologies
  • Model / Serial
    Lot: D130432, expires February 2018
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution and US Nationwide in the states of: CA and PA. United Kingdom.
  • Product Description
    Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. || Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting.
  • Manufacturer
    Blue Belt Technologies MN

Manufacturer

Blue Belt Technologies MN
  • Manufacturer Address
    Blue Belt Technologies MN, 2905 Northwest Blvd Ste 40, Plymouth MN 55441-2673
  • Source
    USFDA