Events

Recall of Vacuum Collection Bottle

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ohio Medical Corporation.

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
    53192
  • Event Risk Class
    Class 2
  • Event Number
    Z-0090-2010
  • Event Initiated Date
    2009-09-21
  • Event Date Posted
    2009-10-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84897
  • 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
    Bottle, collection, vacuum - Product Code KDQ
  • Reason
    The re-useable collection bottles were made with polycarbonate instead of the specified polysulfone. the recommended cleaning of the bottles include use of ammonia and autoclaving, which may have an adverse impact on polycarbonate.
  • Action
    Ohio Medical Corporation issued recall letters beginning September 17, 2009. Consignees were informed of the affected product and requested to return affected collection bottles to the firm. The accounts were requested to complete and return the enclosed acknowledgement form, indicating the number of affected units on hand, to obtain a returned material authorization for the return of the recalled bottles and their replacement. For further information, contact Ohio Medical Quality Assurance Manager, Anita Christ, at 847-855-6270.

Device

Vacuum Collection Bottle
  • Model / Serial
    The bottles are coded with a date stamp on the bottom of the bottle. The affected code is an "E" inside of a circle.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Canada, Chile, Costa Rica, Cyprus, Egypt, El Salvador, Greece, Hong Kong, India, Israel, Japan, Jordan, Korea, Kuwait, Malaysia, Netherlands, Oman, Paraguay, Philippines, Qatar, Saudi Arabia, Singapore, Thailand, Turkey, United Kingdom and Venezuela.
  • Product Description
    Vacuum Collection Bottle, 1 gallon (3200 mL); Ohio Medical Company, Gurnee, IL 60031; part number 0212-0302-600 (6700-209-500); the bottles are sold alone and with various cap & float assemblies: || 0321-7986-800 - Bottle with Straight Wall Bracket, Cap & Float; || 6700-0018-800 - Bottle with V Wall Bracket, Cap & Float; || 6700-0370-800 - Bottle with Floor Bracket, Cap & Float. || The collection bottles are part of a suction bottle assembly which is designed to collect various body fluids.
  • Manufacturer
    Ohio Medical Corporation

Manufacturer

Ohio Medical Corporation
  • Manufacturer Address
    Ohio Medical Corporation, 1111 Lakeside Dr, Gurnee IL 60031
  • Source
    USFDA