Events

Recall of Easy Dial Oxygen Regulator

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
    72449
  • Event Risk Class
    Class 2
  • Event Number
    Z-0272-2016
  • Event Initiated Date
    2015-10-08
  • Event Date Posted
    2015-11-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141042
  • 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
    Regulator, pressure, gas cylinder - Product Code CAN
  • Reason
    These lots of oxygen dial regulators could have the settings label off by one position. when the indicator arrow points to off position, the regulator is actually on the half liter setting (0.50), for the 15 liter. for the 8 liter, instead of being in the off position, the regulator will be in the quarter liter setting (0.25).
  • Action
    The firm sent "Attention Field Corrective Action" letters, dated Oct 8, 2015, to customers. The letter identified the affected device and explained the reason for the recall. The letter provided instructions on how to check the regulator; and asked customers to call the number provided for a replacement if a regulator is labeled incorrectly.

Device

Easy Dial Oxygen Regulator
  • Model / Serial
    Lot numbers 072215 and 072315.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in the US to the states of PA, MA, MO, MT, ID, MI, MN, ND, KY, NY, NC, CA, AL, AZ, LA, OH, TX, GA, IN, and OK.
  • Product Description
    Easy Dial Oxygen Regulator, 168708D and 168715D. || Eight liter from .0.25 to 8 liters, 15 liter from 0.5 liter to 15 liters of oxygen per minute.
  • Manufacturer
    Precision Medical, Inc.

Manufacturer

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