Events

Recall of Device Recall PROTOCOL Blood Pressure Cuff

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Medical Systems Information Technologies.

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
    26287
  • Event Risk Class
    Class 3
  • Event Number
    Z-1237-03
  • Event Initiated Date
    2001-03-07
  • Event Date Posted
    2003-10-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27436
  • 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
  • Reason
    Wrong connector attached to blood pressure cuff.
  • Action
    The recalling firm telephoned the one account involved on 3/7/2001 and also mailed a Recall Notification letter to the firm on 3/7/2001 requesting return of the product.

Device

Device Recall PROTOCOL Blood Pressure Cuff
  • Model / Serial
    Lot 0601
  • Distribution
    Product was distributed to one distributor in Oregon.
  • Product Description
    Infant reusable blood pressure cuffs, one tube, male slip luer connector, P/N 2930 , manufactured for Welch Allyn Protocol, Inc. and labeled in part: '***Reusable Blood Pressure Cuffs Infant 50 Cuffs REF 008-0625-00 PROTOCOL SYSTEMS, INC. Beaverton, OR 97008-7107 USA Assembled in Mexico***.'
  • Manufacturer
    GE Medical Systems Information Technologies

Manufacturer

GE Medical Systems Information Technologies
  • Manufacturer Address
    GE Medical Systems Information Technologies, 4502 Woodland Corporate Blvd., Tampa FL 33614
  • Source
    USFDA