Events

Recall of Device Recall Hudson RCI Infant Nasal CPAP Cannula, Size 0

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
    37665
  • Event Risk Class
    Class 2
  • Event Number
    Z-0857-2007
  • Event Initiated Date
    2007-03-23
  • Event Date Posted
    2007-06-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51254
  • 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
    CPAP - Product Code BZD
  • Reason
    The luer-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate pressure reading.
  • Action
    Teleflex Medical sent Urgent Medical Device Recall letters dated 3/23/07 via UPS 2nd Day Air to the direct accounts, informing them that the luer-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate pressure reading. The accounts were requested to cease use of the affected units, remove them from use/stock, quarantine 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

Device Recall Hudson RCI Infant Nasal CPAP Cannula, Size 0
  • Model / Serial
    catalog no. 1690, lot numbers 32069/21406, 33069/22206, 34069/22606;  catalog no. 41690, lot number 33069/22206; catalog no. 1683, lot number 33069/22106
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Puerto Rico, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Dominican Republic, El Salvador, Germany, Guatemala, Hong Kong, India, Israel, Kuwait, Malaysia, Mexico, New Zealand, Paraguay, Peru, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, and Venezuela
  • Product Description
    Infant Nasal CPAP Cannula, Size 0; an Rx infant nasal prong continuous positive airway pressure (CPAP) cannula one inspiratory and one expiratory elbow connector; 10 units per case; Teleflex Medical, Research Triangle Park, NC 27709 U.S.A., Made in Mexico; The cannulas are sold as components in the following configurations: || a) catalog No. 1690 and 41690 (International): Infant CPAP Set intended for use with mechanical ventilators, which includes one cannula with one inspiratory and one expiratory elbow connector, two 10mm to 7.5mm adapters, one knit cap and two 6 inch sections of Velcro securing tape; || b) catalog No. 1683: Infant CPAP System intended for use with a water seal or spring loaded valve, and includes one cannula with one inspiratory and one expiratory elbow conenctor, two 4 ft. lengths of 10mm I.D. corrugated tubing, one 4 ft. pressure monitoring line, one 22mm to 10mm humidifier adapter, one knit cap and two 6 inch sections of Velcro securing tape;
  • Manufacturer
    Teleflex Medical

Manufacturer

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