Events

Recall of Device Recall No React

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Shelhigh, 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
    34692
  • Event Risk Class
    Class 2
  • Event Number
    Z-0678-06
  • Event Initiated Date
    2006-01-18
  • Event Date Posted
    2006-03-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-05-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44484
  • 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
    Pulmonic Valved Conduit - Product Code MWH
  • Reason
    Unapproved device-distribution of an unapproved device into interstate commerce.
  • Action
    The firm retrieved the 6 devices from the consignees identified, following a telephone request on 1/18/2006. The firm does not consider this a recall.

Device

Device Recall No React
  • Model / Serial
    Model NR4000PA-C (size 6 mm), serial# PE19061, Lot# 030804-NR, Aug 2007 expiration Model NR4000PA-C (size 5 mm), serial# PE19089, Lot# 030924-NR, Sept 2007 expiration Model NR4000PA-C (size 6 mm), serial# PE20073, Lot# 040903-NR, Sept 2008 expiration Model NR4000PA-C (size 5 mm), serial# PE20678, Lot# 050222-NR, Feb 2009 expiration Model NR4000PA-C (size 6 mm), serial# PE20388, Lot# 050103-NR, Jan 2009 expiration Model NR4000PA-C (size 5 mm), serial# PE20677, Lot# 050222-NR, Feb 2009 expiration
  • Product Classification
    Cardiovascular Devices
  • Device Class
    HDE
  • Implanted device?
    Yes
  • Distribution
    The devices were supplied directly to hospital and Shelhigh sales reps. There are two main accounts: Children's Hopsital of Boston, MA and Products for Surgery, Scottsdale, AZ (Shelhigh authorized salesman). The firm subsequently shipped a recalled unit, S/N PE20677 on 11/8/2005 to a European Distributor, Bioplan SRL, Parma, Italy. There are no Govt. accounts.
  • Product Description
    Shelhigh No-React Pulmonic Valve Conduit. **'Shelhigh No-React¿, Pulmonic Valve Conduit, NR4000-PA-C'** **'Shelhigh, Inc., 650 Liberty Ave., Union, NJ 07083 ¿ USA'** **'Shelhigh Porcine Pulmonic Valve Conduit Prosthesis Model NR-4000 Series with 'No-React¿' treatment*, INSTRUCTIONS FOR USE'**.
  • Manufacturer
    Shelhigh, Inc.

Manufacturer

Shelhigh, Inc.
  • Manufacturer Address
    Shelhigh, Inc., 650 Liberty Ave, Union NJ 07083-8130
  • Source
    USFDA