Events

Recall of NEONATE 5 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-105-2, 5082-105-2CL, and sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-114 and 30502-214 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-105-2 and 637-5084-105-2 - Arden, Skaneateles, NY.

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
    28428
  • Event Risk Class
    Class 2
  • Event Number
    Z-0757-04
  • Event Initiated Date
    2004-03-01
  • Event Date Posted
    2004-07-20
  • 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=31829
  • 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
    Gmp deficiencies.
  • Action
    Letters dated 3/1/2004 to customers with instructions to return product. Distributors instructed to notify their customers.

Device

NEONATE 5 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for single patie...
  • Model / Serial
    Code dates between May 13, 2003 and January 23, 2004. (Codes found on outer carton only)
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Direct accounts include distributors, medical facilities, an exporter and 7 foreign consignees.
  • Product Description
    NEONATE 5 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-105-2, 5082-105-2CL, and sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-114 and 30502-214 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-105-2 and 637-5084-105-2 - Arden, Skaneateles, NY.
  • 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