Events

Recall of Device Recall Model 324JL OnBoard Suction System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Impact Instrumentation, 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
    62736
  • Event Risk Class
    Class 3
  • Event Number
    Z-2430-2012
  • Event Initiated Date
    2012-03-30
  • Event Date Posted
    2012-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111554
  • 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
    Apparatus, suction, ward use, portable, ac-powered - Product Code JCX
  • Reason
    A shipment mix-up took place.
  • Action
    The firm, Impact Instrumentation Inc., contacted their customers via phone and email notification on April 9, 2012. Customers were provided the correct packing slip and asked to acknowledge the correction. If you have any questions, contact the Regulatory Affairs Manager at 973-882-1212 or email: aglordano@impactii.com.

Device

Device Recall Model 324JL OnBoard Suction System
  • Model / Serial
    Model 324JL S/N 120142 and S/N 120144
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: FL and OH.
  • Product Description
    Model 324JL On-Board Suction System || Intended use: On-board suction system for Ambulance manufacturers.
  • Manufacturer
    Impact Instrumentation, Inc.

Manufacturer

Impact Instrumentation, Inc.
  • Manufacturer Address
    Impact Instrumentation, Inc., 23 Fairfield Pl, West Caldwell NJ 07006-6206
  • Manufacturer Parent Company (2017)
    Asahi Kasei Corp.
  • Source
    USFDA