Events

Recall of Device Recall JosNoe Medical PS500 Scope Warmer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by JosNoe Medical, 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
    73007
  • Event Risk Class
    Class 2
  • Event Number
    Z-0732-2016
  • Event Initiated Date
    2015-12-01
  • Event Date Posted
    2016-01-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142709
  • 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
    Laparoscopic accessories, gynecologic - Product Code NWV
  • Reason
    Damage to package seals potentially compromising sterility.
  • Action
    On 12/1/2015, notifications were sent to the affected customers via e-mail. The recall notification included a description of the reason for the recall, the affected product, and instructions for identifying and returning the affected product.

Device

Device Recall JosNoe Medical PS500 Scope Warmer
  • Model / Serial
    Lot# G154341 Exp: 4/14/18
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed US (nationwide) and in Canada.
  • Product Description
    PS-500 Scope Warmer; 10 units per box. || Pre-heating scope for laparoscopy surgery.
  • Manufacturer
    JosNoe Medical, Inc.

Manufacturer

JosNoe Medical, Inc.
  • Manufacturer Address
    JosNoe Medical, Inc., 1303 S Main St, Chelsea MI 48118-1483
  • Manufacturer Parent Company (2017)
    Josnoe Medical Inc.
  • Source
    USFDA