Recall of Device Recall Rusch Irrigation Tray w/Bulb

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Lubricant, patient - Product Code KMJ
  • Reason
    The irrigation trays contain alcohol prep pads which are included in the scope of a recall initiated by triad group, due to a potential bacterial contamination.
  • Action
    the firm,Teleflex Medical, sent two "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letters one dated February 24, 2011 and the other dated March 30, 2011 to all consignees and customers. The letters described the product, problem and actions to be taken. The consignees were instructed to communicate the recall to any of their customers who have received product included within the scope of the field corrective action via the customer letter. The customers were informed in the letter of concerns about potential bacterial contamination of the alcohol prep pads in the affected trays. If contaminated alcohol prep pads are used, there is a potential for infection to occur. The customers were instructed "that upon opening the affected trays for use, they should discard the prep pads as medical waste". The customers were also instructed to immediately discontinue use and quarantine any products with the product numbers and lot numbers listed; return the product, and complete and return the Recall Acknowledgement Form, even if they no affected product, via fax to 1-866-804-988, Attn: Customer Service (a customer service representative contact the customer with a Return Goods Authorization number and instructions for the return of the product to Teleflex Medical). If you have any questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.


  • Model / Serial
    Catalogue Number 68895: Lot Numbers: 002516, 002520, 003512, 004513, 005510, 005528, 006510, 007513, 009512, 010507, 011506, 011511, 012514, 901524, 901545, 902506, 902519, 903508, 904511, 905502, 907516, 907528, 908518, 911512 and 912503.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide distribution: USA including states of: AL, AZ, CA, FL, GA, IL, MS, MI, MO, MS, NC, NJ, NH, NY, OH, PA, TX, UT, VA, Puerto Rica and the country of: Canada.
  • Product Description
    Rusch Irrigation Tray w/Bulb Catalogue Number 68895 || For irrigation according to institutional guidelines.
  • Manufacturer


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