FDA Medical Device Recalls (openFDA)
Teleflex, Inc.: Tracheopart Set (Right), Sterile
- Recall number
- Z-2413-2015
- Recalling firm
- Teleflex, Inc.
- Product
- Tracheopart Set (Right), Sterile
- Status
- Terminated
- Initiated
- 2014-11-21
- Posted
- 2015-08-18
- Terminated
- 2017-08-15
- Reason
- Customer complaints reporting that the cobb connector detached from the main connector prior to use.
- Root cause
- Other
- Action
- Recall letters were sent on 11/21/2014 to consignees requesting them to discontinue use and quarantine the products. The letter includes a reply form to be returned. The letter to the distributors requested a sub-recall, and included a recall letter to be sent to their accounts.
- Quantity
- not on file
- Distribution
- AL, AK, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV. WI, DC, Puerto Rico, Canada, Bolivia, Ecuador, Hong Kong, Malaysia, Philippines, Taiwan, Trinidad & Tobago
- Lot, serial or model codes
- Product Code 116401-000750 Batch Number 13FT06, 13GT24, 13JT21, 13IT21R, 13KT23, 13KT23R, 14CT21, 14ET11, 14ET22, 14ET28, 14FT16, 14GT15, 14GT23, 14IT17, 14JT18; Product Code 116401-000850 Batch Number 13IT05, 13IT21R, 13KT05, 13LT08, 14CT16, 14DT19, 14ET10, 14ET22, 14FT16, 14GT05, 14GT18, 14HT03, 14HT09; Product Code 116401-000950 Batch Number 13JT21R, 14CT06, 14CT16, 14DT20, 14ET23, 14FT04, 14GT05, 14GT18, 14HT17, 14IT08
- 510(k) numbers
- ["K951091"]
- PMA numbers
- not on file
- Product code
- BTS
- Firm FEI
- 3011369183
- Firm city
- Wayne
- Firm state
- PA
- 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