Events

Recall of Device Recall Hospitak

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Unomedical, 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
    30526
  • Event Risk Class
    Class 1
  • Event Number
    Z-0288-05
  • Event Initiated Date
    2004-12-02
  • Event Date Posted
    2004-12-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-09-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36126
  • 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
    Connector, Airway (Extension) - Product Code BZA
  • Reason
    Adapters have been found to be blocked or occluded - potentially preventing exhalation or inhalation.
  • Action
    The firm issued a Public Safety Alert on 11/30/2004. The firm expanded their safety alert on 12/02/2004 and issued press informing of a recall. The firm sent recall letters to consignees on 12/02/2004.

Device

Device Recall Hospitak
  • Model / Serial
    Lot Numbers 31304004
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The product was distributed nationwide to hospitals, home healthcare, and medical transport. Distribution to foreign countries included: Canada; Russia; France; Switzerland; Argentina; Uruguay; and Mexico
  • Product Description
    Viasys, REF BLD-14660, Pulmanex Adult Transport Circuit w/ Exhalation Valve, Non-Heated, 60'', manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico
  • Manufacturer
    Unomedical, Inc

Manufacturer

Unomedical, Inc
  • Manufacturer Address
    Unomedical, Inc, 6001 S 35th St, Mcallen TX 78503-8887
  • Source
    USFDA