Events

Recall of Device Recall Deltran Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Utah Medical Products, 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
    65374
  • Event Risk Class
    Class 2
  • Event Number
    Z-1543-2013
  • Event Initiated Date
    2013-06-04
  • Event Date Posted
    2013-06-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118735
  • 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
    Transducer, blood-pressure, extravascular - Product Code DRS
  • Reason
    Utah medical products, inc. is recalling certain deltran disposable pressure transducer kits due to complaints related to packaging integrity of the sterile packaged devices.
  • Action
    Utah Medical Products (UTMD) sent a Recall Notice letter dated June 3, 2013 via fax and email to all affected customers and will be completing follow up telephone calls by June 7, 2013. The letter identified the affected product, problem, health risk, and actions to be taken. UTMD instructed customers to locate and return affected products for exchange. For questions call Customer Service at 800-533-4984.

Device

Device Recall Deltran Kit
  • Model / Serial
    Part number DPT-248A, lot number 1122508.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - United States Nationwide in the states of (MO, NE, KY, FL, OH, NY), and countries of Columbia, Brazil, Venezuela. West Indies, Latin America, Ecuador are distributed through a US direct consignee exporter.
  • Product Description
    Deltran Disposable Pressure Transducer Kit (DPT Kit) || Extracorporeal disposable pressure transducer and tubing set with integral stopcock and flush device, || Product Usage: Deltran is a disposable pressure transducer that provides consistent and accurate readings during invasive blood pressure monitoring of humans and animals.
  • Manufacturer
    Utah Medical Products, Inc

Manufacturer

Utah Medical Products, Inc
  • Manufacturer Address
    Utah Medical Products, Inc, 7043 South 300 West, Midvale UT 84047
  • Manufacturer Parent Company (2017)
    Utah Medical Products, Inc.
  • Source
    USFDA