Z-2412-2015Class II

Tracheopart Set (Left), Sterile

Name: Z-2412-2015 Tracheopart Set (Left), Sterile
Creator: Teleflex, Inc.
Published: 2014-11-21
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2014-11-21 / Terminated

FDA source

Teleflex, Inc. began a recall of Tracheopart Set (Left), Sterile on 2014-11-21. FDA classified it as Class II and gives the reason as "Customer complaints reporting that the cobb connector detached from the main connector prior to use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2412-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-21
Posted: 2015-08-18
Terminated: 2017-08-15
Recalling firm: Teleflex Medical
Product: Tracheopart Set (Left), Sterile
Product code: BTS Tube, Bronchial (W/Wo Connector)
Reason for recall: Customer complaints reporting that the cobb connector detached from the main connector prior to use.
FDA 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.
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
Product codes and lots: Produce Code 116400-000750 Batch Number 13FT06, 13GE28J, 13GE31J, 13GT11, 13GT29, 13IT05, 13IT16, 13JT11, 13JT21R, 13JT25R, 13KT05R, 13LT11, 14BT09, 14BT15, 14CT16, 14CT20, 14DE16J, 14DT19, 14FE24J, 14FT16, 14GE29J, 14GT03, 14GT23, 14HT03, 14HT23, 14IT05, 14IT17; Product Code 116400-000850 Batch Number 13FT18, 13GE31J, 13GT05, 13HT17, 13IT13, 13JT15, 13JT20, 13JT20R, 13KT23R, 13LT08, 14BT09, 14BT15, 14CT16, 14CT20, 14DE15J, 14DT08, 14FE24J, 14FT13, 14GE28J, 14GT18, 14GT21, 14HT09, 14IT05, 14IT14, 14JT04, 14JT12; Product Code 116400-000950 Batch Number 13GE30J, 13GT29, 13HT16, 13IT13, 13LT08, 14AE05J, 14DT10, 14ET11, 14FT04, 14GT21, 14IT08, 14IT14, 14JE43J, 14JT18, 14JT24

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2412-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2407-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-19
Z-2408-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-19
Z-2409-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-19
Z-2410-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-19
Z-2411-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-19
Z-2412-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-19
Z-2413-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-19
Z-2414-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-19
Z-2415-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-19

Product code BTS

K951091Class IIRusch Endobronchial Tube SetsRusch Intl. / cleared 1995-06-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)