Events

Recall of Device Recall Smiths Medical

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
    69842
  • Event Risk Class
    Class 2
  • Event Number
    Z-0897-2015
  • Event Initiated Date
    2014-11-21
  • Event Date Posted
    2014-12-30
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131688
  • 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
    Needle, hypodermic, single lumen - Product Code FMI
  • Reason
    Needle is not captured in the needle safety sheath in specific lots.
  • Action
    Smith Medical sent on 11/24/2014, consignees an Urgent Field Safety Notice via FedEx Overnight. The notification instructs customers to inspect their inventory and complete and return the attached Urgent Field Safety Notice Confirmation Form to coordinate return of affected product to Smiths Medical for replacement/credit. For questions regarding this information, please contact Smiths Medicals Customer Service Department at 800-258-5361.

Device

Device Recall Smiths Medical
  • Model / Serial
    Lot Numbers: 2731779, 2763138, 2771516, 2771517
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of AZ CA FL GA IL IN LA MA MN MO MS MT NC ND NJ NV NY OH OR PA RI TN TX VA WA WI WV
  • Product Description
    Hypodermic Needle Pro¿ Edge" Safety Device 20G x1; Reorder Number: 402010 || Product Usage: || The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.
  • Manufacturer
    Smiths Medical ASD, Inc.

Manufacturer

Smiths Medical ASD, Inc.
  • Manufacturer Address
    Smiths Medical ASD, Inc., 10 Bowman Dr, Keene NH 03431-5043
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Source
    USFDA