Events

Recall of Device Recall DISP. HYPODERMIC NEEDLE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Terumo Medical Corporation.

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
    58863
  • Event Risk Class
    Class 2
  • Event Number
    Z-2798-2011
  • Event Initiated Date
    2010-06-08
  • Event Date Posted
    2011-07-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100438
  • 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
    Hypodermic needle packaging defect could compromise sterility. affected lot numbers are: mc1725, mc2025, mc2025.
  • Action
    The firm, Terumo Medical Corporation sent an "URGENT PRODUCT BULLETIN: RECALL OF TERUMO PRODUCT" letter dated June 8, 2010. Consignees were contacted via telephone on June 7 thru 9, 2010 to confirm receipt of the Product Recall Bulletin. The letter describes the product, problem and the actions to be taken. The letter instructed customers to immediately discontinue use and quarantine any available stock of the listed product codes. The letter stated that distributors must not distribute any of the listed product codes, quarantine any available stock and send the recall bulletin immediately to each customer that received the recalled products to inform them of this issue. Additionally, Terumo Medical Corporation sent a "Terumo Customer Instructions for Returning Recalled Product and Customer Confirmation of Product Recall Notification" letters dated June 8, 2010 to all affected facilities. Customers were instructed to fill-out the requested information and return to Terumo Medical Corporation (TMC) Product Recall Coordinator. Consignees were contacted via telephone on June 8 and 9, 2010 to confirm receipt of the recall information and compliance with the requested action. For questions or need for further information, call (800) 283-7866 and ask to speak with the Product Recall Coordinator.

Device

Device Recall DISP. HYPODERMIC NEEDLE
  • Model / Serial
    Catalog Number 431, Catalog Number 443, Catalog Number 100280
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution (USA) -- AZ, CA, CO, FL, GA, IL, KS, KY, MA, MO, NC, NJ, NY, OH, PA, TN, TX, WA, UT, and VA
  • Product Description
    Terumo(tm) Hypodermic Needle, sterile, individually packaged into a "blister-pack" flexible plastic bottom-web thermo-formed to create a pocket, heat-sealed with paper top-web,1,000 needles per case. || Product Usage: Aspiration and injection of fluids for medical purposes.
  • Manufacturer
    Terumo Medical Corporation

Manufacturer

Terumo Medical Corporation
  • Manufacturer Address
    Terumo Medical Corporation, 950 Elkton Blvd, Elkton MD 21921-5322
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA