Teleflex, Inc.: Bronchial Double Lumen Tube Set (Left), Sterile

Recall number

Z-2407-2015

Recalling firm

Teleflex, Inc.

Product

Bronchial Double Lumen Tube Set (Left), 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

6,991 ea. - US & 136,759 ea. - INTL

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 116100260 Batch Number 13GT24, 13HT07, 13IT16, 13KT23, 14AT08, 14DT19, 14ET10, 14ET11, 14FT04, 14FT10, 14GT03; Product Code 116100280 Batch Number 13GT24, 13KT05, 13KT23, 14AT12, 14ET23; Product Code 116100350 Batch Number 13GT24, 13HT07, 13IT16, 13JT08, 13KT05, 13KT18, 13KT23, 13LT14, 14CT06, 14DT10, 14DT19, 14ET23; Product Code 116100370 Batch Number 13GT11, 13GT24, 13HT07, 13IT16, 13JT25, 13KT23, 13LT04, 13LT18, 14CT11, 14DT13, 14DT19, 14DT24, 14DT25, 14ET10, 13ET11; Product Code 116100390 Batch Number 13FT12R, 13HT07, 13IT16, 13JT11, 13JT15, 13JT25, 13KT18, 13KT23, 14AT12R, 14BT09, 14ET10, 14ET11; Product Code 116100410 Batch Number 13FT12R, 13GT05, 13HT07, 13IT20, 13JT25, 13KT05, 13KT18, 13LT18, 14DT19, 14ET04, 14ET10, 14ET11, 14FT05, 14FT10; Product Code 116100-000260 Batch Number 13FT12, 13FT17, 13GT24, 13HT07, 13HT12, 13HT17, 13IT05, 13IT10, 13IT20, 13IT20R, 13JT05R, 13LT04, 14BT15, 14BT16, 14CT16, 14DE14J, 1DT13, 14ET04, 14ET10, 14GT03, 14GT15, 14GT21, 14HT09, 14HT12, 14HT20, 14IT05, 14IT08, 14JT12, 14JT24; Product Code 116100-000280 Batch Number 13GT16, 13GT23, 13HT17, 13IT10, 13IT13, 13IT16, 13IT20, 13IT20R, 13JT08, 13KT05, 13KT18, 13KT23, 14AT08, 14AT12, 14BT16, 14CT06, 14CT11, 14CT16, 14DE14J, 14DT10, 14DT19, 14DT20, 14DT24, 14ET04, 14ET10, 14ET22, 14ET23, 14FT04, 14FT05, 14GT03, 14GT18, 14HT20, 14IT14, 14JT12; Product Code 116100-000350 Batch Number 13FT06, 13FT12, 13FT17, 13FT18, 13GT23, 13GT24, 13HT07, 13HT12, 13HT17, 13IE36R, 13IT05, 13IT10, 13IT16, 13JT08, 13JT11, 13JT25, 13KT05, 13KT12, 13KT18, 13KT23, 13LT04, 13LT14, 14AT08, 14AT16, 14BT15, 14BT21, 14CT11, 14CT16, 14CT20, 14DT10, 14DT13, 14DT15, 14DT19, 14ET04, 14ET05, 14ET22, 14ET23, 14ET28, 14FT04, 14GT05, 14GT10, 14HT09, 14HT12, 14HT17, 14HT20, 14IT05, 14IT17, 14JT04, 14JT09, 14JT12, 14JT21, 14JT24; Product Code 116100-000370 Batch Number 13FT06, 13FT12, 13FT18, 13GE27J, 13GE31J, 13GT05, 13GT11, 13GT16, 13GT24, 13GT29, 13HT07, 13HT12, 13HT17, 13IT05, 13IT10, 13IT16, 13IT20R, 13JT05, 13JT05R, 13JT08, 13JT15, 13JT21, 13KT05, 13KT12, 13KT15, 13LT04, 13LT11, 13LT14, 13LT18, 14AT08, 14AT12, 14AT16, 14AT20, 14BT14, 14BT15, 14BT16, 14CT06, 14CT11, 14CT21, 14DT03, 14DT10, 14DT13, 14DT24, 14DT25, 14ET04, 14ET10, 14ET22, 14ET23, 14ET28, 14FE23J, 14FT04, 14FT05, 14FT10, 14GT03, 14GT05, 14GT10, 14GT15, 14GT18, 14GT23R, 14HT09, 14HT12, 14HT17, 14HT23, 14HT24, 14IT05, 14IT08, 14IT11, 14IT17, 14JT04, 14JT12, 14JT18, 14JT21, 14JT24; Product Code 116100-000390 Batch Number 13FT06, 13FT12, 13FT17, 13FT18, 13GT05, 13GT16, 13GT24, 13GT29, 13HE35, 13HT07, 13HT16, 13HT17, 13IT10, 13IT13, 13JT05, 13JT08, 13JT11, 13JT15, 13JT20, 13JT21, 13JT25, 13KT05, 13KT12, 13KT18, 13KT23, 13LT04, 13LT14, 14BT09, 14BT14, 14BT15, 14BT16, 14BT21, 14CT06, 14CT11, 14CT20, 14DT03, 14DT06, 14DT10, 14DT13, 14DT15, 14DT24, 14DT25, 14EE21J, 14ET04, 14ET10, 14ET22, 14ET28, 14FT04, 14FT05, 14FT10, 14FT13, 14GT03, 14GT05, 14GT15, 14GT18, 14HT03R, 14HT09, 14HT12, 14HT17, 14IT05, 14IT11, 14IT14, 14IT17, 14JT04, 14JT09, 14JT12, 14JT21; Product Code 116100-000410 - Batch Number 13FT06, 13FT12, 13FT18, 13GT05, 13GT11, 13GT16, 13GT23, 13GT29, 13HT07, 13HT12, 13HT17, 13IT05, 13IT10, 13IT16, 13IT20, 13IT20R, 13JT08, 13JT15, 13KT05, 13KT12, 13KT18, 13KT23, 13LT04, 13LT08, 13LT14, 13LT18, 14AT08, 14AT16, 14AT20, 14BT15, 14CT06,14CT11, 14CT16, 14CT20, 14DT06, 14DT10, 14DT13, 14DT24,14EE21J, 14ET04, 14ET05, 14ET10, 14ET22, 14FT10, 14FT13, 14FT16, 14FT20, 14GT05, 14GT15, 14GT18, 14HT03, 14HT09, 14HT17, 14HT24, 14IT05, 14IT08, 14IT17, 14JT09, 14JT12, 14JT21; Product Code 16100-000350 Batch Number 14DE14J, 14FE24J, 14GE28J

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

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

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