Events

Recall of Device Recall Unolok

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Myco Medical Supplies 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
    72616
  • Event Risk Class
    Class 2
  • Event Number
    Z-0444-2016
  • Event Initiated Date
    2015-11-06
  • Event Date Posted
    2015-12-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141671
  • 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
    Particulates: complaints of rubber coring from the closure of injection vials.
  • Action
    MYCO Medical sent an Advisory Notice dated November 6, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory, if any affected product found MYCO request that the customer return the product to MYCO Medical following the instructions provided on the Materials for Return Form. Customers with questions were instructed to call Customers Service at 919-460-2535/ customerservice&mycomedical.com; or cal the Quality Department at 919-460-2535/ QA@mycomedical.com.

Device

Device Recall Unolok
  • Model / Serial
    Item #02463, Lot numbers: 19351R, 16561M, 17531D, 22541D, 22551D, 25551D and 25551M.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MI, NJ, NY, NV, OK, PA, TX and UT.
  • Product Description
    Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, || Single use, non-injection needle
  • Manufacturer
    Myco Medical Supplies Inc

Manufacturer

Myco Medical Supplies Inc
  • Manufacturer Address
    Myco Medical Supplies Inc, 158 Towerview Ct, Cary NC 27513-3595
  • Manufacturer Parent Company (2017)
    Myco Medical Supplies Inc.
  • Source
    USFDA