Events

Recall of Hudson RCI

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
    69194
  • Event Risk Class
    Class 1
  • Event Number
    Z-2714-2014
  • Event Initiated Date
    2014-09-08
  • Event Date Posted
    2014-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129831
  • 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
    Circuit, breathing (w connector, adaptor, y piece) - Product Code CAI
  • Reason
    The pediatric breathing circuits can crack prior to and during use.
  • Action
    Teleflex Medical sent an Urgent Medical Device Recall dated September 8, 2014, to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to immediately discontinue use, quarantine any products with the product codes and lot numbers provided in the notification, return any affected product, complete and return the enclosed Recall Acknowledgement Form and fax it to the attention of Customer Service. For questions contact your local sales representative or Customer Service at 1-866-246-6990.

Device

Hudson RCI
  • Model / Serial
    Product Code: 313905, Lot #02F1300085; Product Code: 353900, Lot #02D1300584; Product Code: 353901, Lot #0241300618; Product Code: 353911, Lot #02G1300296, 02G1300861, 02F1300729; Product Code: 313901, Lot #02G1300088; Product Code: 353811, Lot #02E1300090; 02E1301383 & 02E1301867; Product Code: 353911, Lot #02F1300102 & 02F1300177; Product Code: 353900, Lot #02F1302029; Product Code: 353801, Lot #02E1300623, 02FF1300098, 02H1300172, 02H1300454, 02H1301128, 02F300180, 02E1301891, 02J1300876, 02H1301838, 02J1302412 & 02B1400324; Product Code: 353901, Lot #02E1301378; Product Code: 353900, Lot #02E1301892, 02F1300100 and Product Code: 353901, Lot #02F1302047, 02F1300101 & 2G1300879.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of AZ, CA, FL, IL, KY, OH, NJ, NY, TX, LA, OR, SD, WA, including Puerto Rico, and the countries of Belgium, Canada, Chile, China, Colombia, Korea, Mexico, Peru, Venezuela and Zaire.
  • Product Description
    Hudson RCI¿ Pediatric Anesthesia Breathing Circuits, Single Patient Use, Rx Only, || Product Usage: To administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Ypiece.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA