Events

Recall of Evergreen.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Unomedical.

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
    53489
  • Event Risk Class
    Class 1
  • Event Number
    Z-0046-2010
  • Event Initiated Date
    2009-10-06
  • Event Date Posted
    2009-11-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-08-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85670
  • 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
    Manual Pulmonary Resuscitator - Product Code BTM
  • Reason
    In some manual pulmonary resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the mpr bag/body. if this occurs, the mpr may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.
  • Action
    Unomedical issued Press on October 6, 2009. Letters were sent to customers on October 7, 2009 via UPS - return receipt. Letters explained the reason for recall and the potential hazard to patients. The letter contains a list of all affected lot numbers as well as a picture which shows that units with a clearly visible blue ring are NOT affected. Distributors are asked to examine inventory and quarantine all affected product and return the response form, even if no recalled product is in inventory. If the product was further distributed, the letter requests that a copy of the letter be sent to all customers and for returns, follow Distributor actions listed in the letter. Retailers and end users/Hospitals/EMT's are asked to perform a count of recalled product, segregate it and return the response form. All customers are asked to call 1-800-634-6003 where they will be assigned a RGA number and given instructions on how to return product. Contact information: 8:00AM - 5:30 PM Central Time Monday through Thursday and 8:00AM to 1:00 PM on Fridays, Central Time.

Device

Evergreen.
  • Model / Serial
    Product ID # 12-8708; lot numbers: 03-46 03-47
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, Argentina, Canada, Denmark, France, Greece, India, Italy, Japan, Mexico, Paraguay, Peru, Poland, Russia and Vietnam.
  • Product Description
    Pediatric Manual Pulmonary Resuscitator. Product ID # 12-8708. || Packaged under the name of Evergreen.
  • Manufacturer
    Unomedical

Manufacturer

Unomedical
  • Manufacturer Address
    Unomedical, 5701 S Ware Rd, Mcallen TX 78503-7795
  • Manufacturer Parent Company (2017)
    Triona Holding Sa
  • Source
    USFDA