Events

Recall of Device Recall Sterile Access & Return Line Set

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
    64471
  • Event Risk Class
    Class 2
  • Event Number
    Z-0969-2013
  • Event Initiated Date
    2012-06-19
  • Event Date Posted
    2013-03-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116207
  • 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
    The recalled product leaks at the connection site.
  • Action
    The firm's one customer was notified of the recall by phone call on 5/8/2012. The customer returned the affected product once the replacement product was received.

Device

Device Recall Sterile Access & Return Line Set
  • Model / Serial
    Lot numbers: 80106 and 80106b
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to one customer in Michigan.
  • Product Description
    Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. || Intended for use with medically prescribed hemodialysis blood tubing.
  • 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