FDA Medical Device Recalls (openFDA)
Teleflex Medical: Rusch Irrigation Tray w/Piston Catalogue Number 67890 For irrigation according to institutional guidelines.
- Recall number
- Z-1896-2011
- Recalling firm
- Teleflex Medical
- Product
- Rusch Irrigation Tray w/Piston Catalogue Number 67890 For irrigation according to institutional guidelines.
- Status
- Terminated
- Initiated
- 2011-02-24
- Posted
- 2011-04-05
- Terminated
- 2012-04-17
- 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.
- Root cause
- Other
- 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.
- Quantity
- 95,647 eaches (total for both Catalogue Numbers)
- 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.
- Lot, serial or model codes
- Catalogue Number 67890, Lot numbers: 002508, 002514, 002519, 004514, 005508, 006509, 007510, 009511, 010502, 011502, 011510, 901526, 901543, 902507, 904510, 905501, 906512, 907509, 908502, 908524 and 911513.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KMJ
- Firm FEI
- 3005747797
- Firm city
- Durham
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28