Events

Recall of Rusch Neoprene Pecan Shaped Breathing Bag

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

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
    36788
  • Event Risk Class
    Class 2
  • Event Number
    Z-0244-2007
  • Event Initiated Date
    2006-10-31
  • Event Date Posted
    2006-12-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-11-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49359
  • 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
    Breathing Bag - Product Code BYW
  • Reason
    Mislabeling-the rebreathing bag is incorrectly labeled as a 1 liter bag when it is actually a 1/2 liter bag.
  • Action
    Teleflex Medical sent Urgent Medical Device Recall letters dated 10/31/06 via UPS overnight to the direct accounts, informing them that the product was incorrectly labeled as a 1 liter bag when the correct volume of the bag is ¿ liter, and requesting that they cease use of the affected units and destroy them. If the accounts further distributed the product, they were requested to conduct a sub-recall of the affected units from their customers. The accounts were instructed to complete and return by fax the enclosed Acknowledgement & Stock Status Form, indicating the number of units destroyed and if they are requesting replacement product. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.

Device

Rusch Neoprene Pecan Shaped Breathing Bag
  • Model / Serial
    Catalog Number (REF) 21176AP, lot number 070318-1
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide including the states of California and Florida
  • Product Description
    Rusch (Latex Free) Neoprene Pecan Shaped Breathing Bag with 15 mm neck insert, size 1 liter; a rebreathing bag; Teleflex Medical, Bannockburn, IL 60015 USA, Made in UK
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 2345 Waukegan Rd Ste 120, Bannockburn IL 60015-1580
  • Source
    USFDA