Events

Recall of Device Recall NonSterile Double DIN to DIN "Y" Connector

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Molded Products 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
    76760
  • Event Risk Class
    Class 2
  • Event Number
    Z-1679-2017
  • Event Initiated Date
    2015-01-20
  • Event Date Posted
    2017-03-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154105
  • 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
    Accessories, blood circuit, hemodialysis - Product Code KOC
  • Reason
    A customer relayed a complaint of a leaking dialysis tubing connector.
  • Action
    On 1/20/2015, the recalling firm requested the firm's customer to return units from the affected lot.

Device

Device Recall NonSterile Double DIN to DIN "Y" Connector
  • Model / Serial
    40013
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to Ontario, Canada.
  • Product Description
    Non-Sterile Double DIN to DIN "Y" Connector, || Product Usage: || Extension for connecting hemodialysis blood tubing to the hemodialyzer.
  • Manufacturer
    Molded Products Inc

Manufacturer

Molded Products Inc
  • Manufacturer Address
    Molded Products Inc, 1112 Chatburn Ave, Harlan IA 51537-2007
  • Manufacturer Parent Company (2017)
    Molded Products Inc.
  • Source
    USFDA