Events

Recall of Device Recall Low Volume Extension Set, 72

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
    71142
  • Event Risk Class
    Class 2
  • Event Number
    Z-1730-2015
  • Event Initiated Date
    2015-05-04
  • Event Date Posted
    2015-06-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-01-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136224
  • 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
    Set, administration, intravascular - Product Code FPA
  • Reason
    Smiths medical has become aware of an issue with the low volume extension set, (72'' extension set) where under-sized tubing was used in the production of 1 lot of product.
  • Action
    Smiths Medical sent Urgent Medical Device Recall Notice letters, dated 4 May 2015, requiring its customers to return all affected unused Extension Sets. Please take the following actions: 1. Customers are to inspect their inventory and quarantine any affected Extension Sets. 2. Complete and return the attached Confirmation Form by Fax or by e-mail 3. Upon receipt of the completed form, a customer service representative will contact customers to arrange for exchange of their unused affected Extension Sets for credit or replacement. The notice shall be passed on to all personnel who need to be aware, including points of use. If these affected Extension Sets have been further distributed to other persons or facilities, please promptly forward the recipients a copy of this Urgent Medical Device Recall Notice.

Device

Device Recall Low Volume Extension Set, 72
  • Model / Serial
    Product Reorder Number: 537235C; Lot #2761409
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to the states of KY, MN, NJ, UT, & WI.
  • Product Description
    Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. || Used to administer fluid and drugs intravenously.
  • Manufacturer
    Smiths Medical Asd Inc

Manufacturer

Smiths Medical Asd Inc
  • Manufacturer Address
    Smiths Medical Asd Inc, 6250 Shier Rings Rd, Dublin OH 43016-1270
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Source
    USFDA