Events

Recall of Device Recall Rsch FlexiSlip

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
    72037
  • Event Risk Class
    Class 2
  • Event Number
    Z-0245-2016
  • Event Initiated Date
    2015-08-24
  • Event Date Posted
    2015-11-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139626
  • 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
    Stylet, tracheal tube - Product Code BSR
  • Reason
    Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet.
  • Action
    Consignees were notified by letter on 08/24/2015. They were instructed to immediately discontinue use and quarantine any products with the listed catalog numbers. They were to return the product, complete the enclosed Recall Acknowledgement Form and fax or e-mail to recalls@teleflex.com, even if they do not have any of the affected stock. Distributors were instructed to communicate the recall to any of their customers who have received the affected product and to have the customers return any affected product to them with the completed Recall Acknowledgement Form.

Device

Device Recall Rsch FlexiSlip
  • Model / Serial
    Material #502501, Batch numbers: 12EE20, 12FE26, 12GE27, 12IE37, 12GE30, 13AG21, 12LG29, 12IE36, 12IE39, 13DG06, 12JE41, 12KE48, 13BG26, 13BG36, 13DG24, 14FG03, 14GG01, 14GG03, 14HE32, 14HE34, 14IE36, 14KG11, 14JG05, 14JE43, 14KG27, 14LG06, 15BG05, 15AG34, 15AG28, 15CG24, 15DE18, 15DG38, and 15EG08.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- U.S. Nationwide; International Distribution: Argentina, Austria, Belgium, Belgrade, Cameroon, Canada, Chile, Costa Rica, Croatia, Czech Republic, Ecuador, Denmark, Estonia, Finland, France, French Polynesia, Great Britain, Greece, Guyana, Hong Kong, Ireland, Italy, Jordan, Kuwait, Latvia, Lebanon, Martinique, Netherlands, Panama, Peru, Poland, Portugal, Reunion, Romania, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Venezuela, and the United Arab Emirates.
  • Product Description
    R¿sch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex Medical.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 2917 Weck Dr, Research Triangle Park NC 27709-0186
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA