Events

Recall of Device Recall Easy Go Vac

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Precision 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
    30500
  • Event Risk Class
    Class 2
  • Event Number
    Z-0307-05
  • Event Initiated Date
    2004-11-09
  • Event Date Posted
    2004-12-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36012
  • 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
    Pump, Portable, Aspiration (Manual Or Powered) - Product Code BTA
  • Reason
    Battery charger can be overcharged and overheat.
  • Action
    The recalling firm sent Recall letters via first class mail on 11/15/04 to their consignees. The recalling firm will replace the chargers free of charge.

Device

Device Recall Easy Go Vac
  • Model / Serial
    Serial Numbers:008360 to 14360 Charger part number 503974 (Globtek Part # GTM21097CC-5015-1.3 Part No: GS-307-B)
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to medical supply companies and medical facilities nationwide. The product was also shipped to Saudi Arabia, Boliva, Hong Kong, Israel, Brazil, Phillipines, Poland, Canada, Ireland, New Zealand, France, United Kingdom, and Singapore.
  • Product Description
    Easy Go Vac Aspirator, Model PM65. Portable suction unit
  • Manufacturer
    Precision Medical, Inc.

Manufacturer

Precision Medical, Inc.
  • Manufacturer Address
    Precision Medical, Inc., 300 Held Dr, Northampton PA 18067-1150
  • Source
    USFDA