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-0422-2012
  • 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=105681
  • 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: 1961565 1967233 1967234 1967235 1967236 1967237 1967238 1967239 1967240 1973118 1973119 1982938 1982939 1983243 1983244 1983246 1989241 1989242 1989243 1989244 1989245 1995431 1995554 1995555 1995556 1995698 1995699 1995700 1995701 1995702 2007275 2007276 2007277 2007278 2019640 2019641 2019642 2019643 2019644 2025123 2025125 2025126 2025127 2025128 2025129 2025130 2025131 2025133 2025134 2025135 2033081 2033082 2033083 2033084 2033085 2033086 2042613 2042614 2042615 2042617 2042618 2049316 2049317 2049318 2049437 2049438 2055173 2055174 2055175 2055176 2059473 2059474 2059475 2064014 2064015 2064017 2064018 2068138 2068139 2068140 2068141 2068142 2077203 2077204 2077205 2077206 2077207 2083507 2083508 2084305 2090782 2090783 2093663 2093664 2095298 2095300 2101204 2101205 2101206 2101207 2101208
  • 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 Codes L-70 || 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