Events

Recall of Device Recall RUSCH

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
    68387
  • Event Risk Class
    Class 2
  • Event Number
    Z-1851-2014
  • Event Initiated Date
    2014-05-23
  • Event Date Posted
    2014-06-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-01-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127500
  • 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
    Tube, tracheal (w/wo connector) - Product Code BTR
  • Reason
    Although the natural rubber latex caution symbol is clearly displayed on the product label, the accompanying caution statement "caution: this product contains natural rubber latex which may cause allergic reactions" was not printed on the product label.
  • Action
    Teleflex Medical sent a Urgent Medical Device Recall Notification dated June 6, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate that you have received products that are subject to this recall. We are now notifying our customers to take the following actions: 1. If you have affected stock, immediately discontinue use and quarantine any products with the catalog numbers listed above from the lot numbers listed on the attachment. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-866- 804-9881, Attn: Customer Service. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service. This will allow us to document your receipt of this letter. Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

Device

Device Recall RUSCH
  • Model / Serial
    Product Code: 102004040, Lot #13371, 13381, 13291, 13281, 13251 & 13231; Product Code: 102004050, Lot #13461, 13441, 13401, 13431, 13421, 13381, 13371, 1329, 13301, 13311, 13361, 13261, 13231, 13251 & 13241; Product Code: 102004060, Lot #13441, 13451, 13431, 13411, 13381, 13361, 13311, 13301, 13281, 13271, 13261, 13241 & 13231; Product Code: 102004070, Lot #13441, 13421, 13381, 13351, 13291, 13311, 13271 & 13261; Product Code: 102004070, Lot #13251 & 13241; and Product Code: 102004080, Lot #13371, 13301 & 13251.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution and the country of Colombia.
  • Product Description
    RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy-Rusch, GmbH. || A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.
  • Manufacturer
    Teleflex Medical

Manufacturer

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