Events

Recall of Device Recall PM1000 Flow Selector

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
    55117
  • Event Risk Class
    Class 2
  • Event Number
    Z-1561-2010
  • Event Initiated Date
    2010-03-05
  • Event Date Posted
    2010-05-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89941
  • 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
    Ventilator, Emergency, Manual (Resuscitator) - Product Code BTM
  • Reason
    The on/off outlet is mislabeled so that when a user/operator turns selector to "on", it actually may be turned "off".
  • Action
    The recalling firm issued Customer Alert Product Recall letters on 3/5/10 to inform users of the problem and how to identify affected product.

Device

Device Recall PM1000 Flow Selector
  • Model / Serial
    Lot numbers 1209 and 0110
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were shipped to distributor and medical facilities nationwide. The products were also shipped to Taiwan, Germany, Hong Kong, Canada
  • Product Description
    PM1000 Flow Selector - An accessory to an emergency ventilator (resuscitator). The selector is attached to a flowmeter and is used to direct the outlet flow from any standard flowmeter to any one of the three outlets it provides.
  • Manufacturer
    Precision Medical, Inc.

Manufacturer

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