Events

Recall of Device Recall Welch Allyn ProBP 2400 Digital Blood Pressure Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Welch Allyn 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
    76552
  • Event Risk Class
    Class 2
  • Event Number
    Z-1777-2017
  • Event Initiated Date
    2017-02-27
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153506
  • 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
    System, measurement, blood-pressure, non-invasive - Product Code DXN
  • Reason
    A defective electrical component in the battery charging circuit in two lots of the probp 2400 may potentially cause an over-voltage battery charging condition when the device is connected to the external power supply/battery charger. this potential defect resides with the device, not the battery. the over-voltage condition can result in high nimh battery temperatures that, in some cases, can reach levels sufficient to cause melting of the plastic battery door and other adjacent plastic and foam device components.
  • Action
    Welch Allyn sent an Urgent Medical Device Recall letter and Response Forms dated February 21, 2017. They were mailed to the first round of customers beginning on Monday February 27, 2017, via US Postal Service Priority Mail. Welch Allyn will follow up with second round of mailings to the additionally identified end users the week of March 20, 2017. All end users will be instructed to confirm that their unit is affected; and if affected, a replacement unit will be provided so that the affected unit can be returned and scrapped. --- Of the 1120 units, a total of 981 units were distributed from Welch Allyn warehouses and 139 units remained under Welch Allyn control and were not distributed. These units have since been destroyed. For further questions, please call (844) 360-8220.

Device

Device Recall Welch Allyn ProBP 2400 Digital Blood Pressure Device
  • Model / Serial
    Lot Number 0715: Serial Number range (21)07150001 -  (21)07150620; Lot Number 1215: Serial Number range (21)12150001 -  (21)12150500; --- Note: (21) is NOT part of the serial number. It is the Global Unique Device Identification (GUDI) Application Identifier that precedes the serial number on any GUDI compliant label.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution
  • Product Description
    Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in China --- Distributed by Welch Allyn Inc., 4341 State Street Road, Skaneateles Falls, NY 13153 --- Microlife Corporation 9F, 431, RuiGuang Road, NeiHu, Taipei, 11492, Taiwan, R.O.C. --- Microlife AG Espenstrasse 139 9443 Widnau, Switzerland
  • Manufacturer
    Welch Allyn Inc

Manufacturer

Welch Allyn Inc
  • Manufacturer Address
    Welch Allyn Inc, 4341 State Street Rd, Skaneateles Falls NY 13153-5300
  • Manufacturer Parent Company (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA