Events

Recall of Device Recall Hudson RCI One Way Valve

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Telefelx 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
    53960
  • Event Risk Class
    Class 2
  • Event Number
    Z-0652-2010
  • Event Initiated Date
    2009-12-02
  • Event Date Posted
    2010-01-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-08-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86949
  • 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
    Airway connector (Extension) - Product Code BZA
  • Reason
    Products 1664 and 1665 are each one-way valves that offer low flow resistance, each in one, opposite direction. each of these valves demonstrate the appropriate direction with a red arrow. the reason for this recall is incorrect packaging; product code 1664 was incorrectly packaged as product code 1665. if the red arrows are not followed, the valve may be placed in the circuit in the wrong.
  • Action
    Consignees were notified by letter via next day delivery. Each consignee was sent a letter requesting acknowledgement of the recall and a request to return all of the affected product. Each consignee that is a distributor was instructed to forward the letter to their consignees to retrieve relevant product from those locations. A second mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the first mailing. A third mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the second mailing or as an alternative, they may be contacted by phone, e-mail, or fax. A record of these contacts will be maintained. Affected products received by Teleflex will be destroyed or reworked and replacement product or credit will be provided to the consignees. Records of destruction or rework will be maintained. Questions are directed to the firm's sales representatives or to Teleflex Customer Service at 1-866-246-6990

Device

Device Recall Hudson RCI One Way Valve
  • Model / Serial
    Catalog number: 1665, Lot number: 02J0901967
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    CA, IL, NE, NJ, TX, VA, WI and Canada.
  • Product Description
    Hudson RCI One Way Valve, 22mm E.D. to 22mm O.D., REF 1665, Rx Only, Teleflex Medical, Research Triangle park, NC 27709
  • Manufacturer
    Telefelx Medical

Manufacturer

Telefelx Medical
  • Manufacturer Address
    Telefelx Medical, 2917 Weck Drive, Durham NC 27709
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA