Events

Recall of NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable one piece cuff, for single patient use only. Sold under the Welch Allyn ''Tycos'' and Allegiance ''Tactics'' labels. The ''4'' represents the cuff size. (4 = 6.9 to 11.7 cm). These are sold in various configurations and assigned different part numbers. Devices are labeled as follows: || Welch Allyn Tycos #5082-104-2 (10 pack/2 tubes); || Welch Allyn Tycos #5082-104-2CL (10 pack/2 tubes, with clamp); || Welch Allyn Tycos #5082-241-10 (5 pack/2 tubes, multi-size pack); || Allegiance Tactics #30502-113 (case of 40/2 tubes); || Allegiance Tactics #30502-213 (case of 40/2 tubes, with clamp); || Welch Allyn Tycos/Allegiance #5082-241-16 || Firm on the label: (1) Welch Allyn Tycos and Tycos/Allegiance label (package insert and shipping case only): ''Welch Allyn, Inc., Skaneateles Falls, NY''; (2) Allegiance Tactics label ''Distributed by: Allegiance Healthcare Corp., McGaw Park, IL 60085-6787 USA''.

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
    27522
  • Event Risk Class
    Class 2
  • Event Number
    Z-0245-05
  • Event Initiated Date
    2003-10-27
  • Event Date Posted
    2003-12-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-09-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30062
  • 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
    Blood Pressure Cuff - Product Code DXQ
  • Reason
    Incorrect location of inflatable portion of cuff that may result in cuff falling off patient's arm, error code when used with patient monitor, or an inaccurate reading.
  • Action
    Letters dated October 27, 2003 to wholesalers/ distributors with instructions to remove/return product and notify end users.

Device

NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable one piece cuff, for single pa...
  • Model / Serial
    Code dates between June 20, 2003 and October 8, 2003. (Codes found on outer carton only.)
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was sold thru 11 distributors. The product was shipped to end users nationwide. There is one foreign distributor in Singapore. In addition, Welch Allyn shipped product to their affiliates in Ireland, Australia, and South Africa.
  • Product Description
    NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable one piece cuff, for single patient use only. Sold under the Welch Allyn ''Tycos'' and Allegiance ''Tactics'' labels. The ''4'' represents the cuff size. (4 = 6.9 to 11.7 cm). These are sold in various configurations and assigned different part numbers. Devices are labeled as follows: || Welch Allyn Tycos #5082-104-2 (10 pack/2 tubes); || Welch Allyn Tycos #5082-104-2CL (10 pack/2 tubes, with clamp); || Welch Allyn Tycos #5082-241-10 (5 pack/2 tubes, multi-size pack); || Allegiance Tactics #30502-113 (case of 40/2 tubes); || Allegiance Tactics #30502-213 (case of 40/2 tubes, with clamp); || Welch Allyn Tycos/Allegiance #5082-241-16 || Firm on the label: (1) Welch Allyn Tycos and Tycos/Allegiance label (package insert and shipping case only): ''Welch Allyn, Inc., Skaneateles Falls, NY''; (2) Allegiance Tactics label ''Distributed by: Allegiance Healthcare Corp., McGaw Park, IL 60085-6787 USA''.
  • 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