Events

Recall of Device Recall Hotline Administration Sets

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smiths Medical ASD, 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
    60516
  • Event Risk Class
    Class 2
  • Event Number
    Z-0426-2012
  • Event Initiated Date
    2011-11-21
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105685
  • 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
    Warmer, thermal, infusion fluid - Product Code LGZ
  • Reason
    Disconnected/ loose luer connectors at the patient end of the triple lumen tubing of the hotllne disposable administration sets and level 1 d/di-60hl normothermic iv administration sets.
  • Action
    Smiths Medical notified consignees by letter dated November 28, 2011 titled: Urgent Field Safety Notice. The letter identified the affected product, the problem, and the actions to be taken. Customers were instructed to inspect inventory and segregate unused affected product. Distributors were instructed to immediately stop distributing and quarantine all inventory. The letters included a Confirmation Form to be complete and return, by fax to 781-610-9859 or by email to hotlineconnectorrecall@smiths-medical.com. For questions consignees were instructed to contact Smiths Medical at 1781-763-9330.

Device

Device Recall Hotline Administration Sets
  • Model / Serial
    Lot Numbers: 1974580 2007256 2064012 2089416 2093985
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution  (USA) (nationwide) - Argentina, Austria, Australia, Belgium, Bahrain, Bermuda, Canada, Chile, China, Columbia, Czech Republic, Germany, Denmark, Estonia, Egypt, Finland, France, Great Britain, Guernsey, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Israel India, Iceland, Italy, Japan, South Korea, Kazakhstan, Lebanon, Luxembourg, Mexico, Malaysia, New Caledonia, Netherlands, Norway, New Zealand, Panama, Poland, Portugal, Qatar, Singapore, Sweden, Slovak Republic, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, and Vatican City State.
  • Product Description
    HOTLlNE¿ Disposable Administration Sets, || Product Code L-80 || Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE¿ Routine Flow Blood and Fluid Warmers (HL-90 and HL-290), for the warming and delivery of blood and I.V. solutions, at normothermic flow rates of 50 - 5,000 ml/hr.
  • Manufacturer
    Smiths Medical ASD, Inc.

Manufacturer

Smiths Medical ASD, Inc.
  • Manufacturer Address
    Smiths Medical ASD, Inc., 160 Weymouth St, Rockland MA 02370-1136
  • Source
    USFDA