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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Teleflex, Inc.: Customer complaints reporting that the cobb connector detached from the main connector prior to use.

Agency Publication Date: August 18, 2015
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Affected Products

Product: Bronchial Double Lumen Tube Set (Left), Sterile

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

Lot Numbers:
116100260
Number
116100280
Number
116100350
Number
116100370
Number
116100390
Number
116100410
Number
116100-000260
Number
116100-000280
Number
116100-000350
Number
116100-000370
Number
116100-000390
Number
116100-000410
Number
16100-000350
Number
Product: Bronchial Double Lumen Tube Set (Right), Sterile

Product Code 162000260 Batch Number 14CT11; Product Code 116200280 Batch Number 13JT05, 13KT18, 14CT11, 14FT05, 14FT10; Product Code 116200350 Batch Number 13FT12R, 13GT11, 13HT07, 13KT23, 14AT08; Product Code 116200370 Batch Number 13KT23, 13LT14, 14DT25, 14ET23; Product Code 116200390 Batch Number 13HT12, 13JT08, 13KT18, 14ET10; Product Code 116200410 Batch Number 14ET05, 14ET22; Product Code 116201350 Batch Number 13FT12R, 13GT05; Product Code 116201410 Batch Number 14ET04; Product Code 116200-000260 Batch Number 13FT12, 13GE29J, 13GT29, 13HT12, 13HT17, 13IT10, 13JT05R, 13JT21, 13LT04, 14DT03, 14ET04, 14ET10, 14ET22, 14FT04, 14GT11, 14GT18, 14GT21, 14HT09, 14HT17; Product Code 116200-000260 - Batch Number 13FT12, 13GE29J, 13GT29, 13HT12, 13HT17, 13IT10, 13JT05R, 13JT21, 13LT04, 14DT03, 14ET04, 14ET10, 14ET22, 14FT04, 14GT11, 14GT18, 14GT21, 14HT09, 14HT17; Product Code 116200-000280 Batch Number 13FT06, 13FT12, 13GE29J, 13HT12, 13HT17, 13IT10, 13JT11, 13KT05, 13KT18, 13LT11, 14CT06, 14CT21, 14DT10, 14DT24, 14ET10, 14ET22, 14FT04, 14FT10, 14GT03, 14GT15, 14GT21, 14HT09, 14IT05, 14IT20; Product Code 116200-000350 Batch Number 13GE28J, 13GT05, 13GT11, 13GT23, 13GT29, 13HT07, 13HT12, 13HT17, 13IT10, 13IT13, 13JT08, 13JT20, 13JT21, 13KT05, 13KT12, 13KT23, 13LT04, 13LT08, 13LT11, 14AT04, 14AT08, 14BT21, 14CT06, 14CT16, 14CT20, 14CT21, 14DT06, 14DT24, 14ET04, 14ET05, 14FT22, 14FT04, 14FT10, 14FT13, 14FT20, 14GT05, 14GT15, 14HT09, 14HT20, 14HT23, 14IT05, 14IT08, 14JT09, 14JT12, 14JT24; Product Code 116200-000370 Batch Number 13FT17, 13GE28J, 13GT05, 13GT16, 13HT12, 13IT05, 13IT10, 13IT16, 13IT20R, 13JT08, 13JT15, 13KT05, 13KT12, 13KT23, 13LT08, 13LT14, 14AT08, 14AT12, 14BT21, 14CT06, 14CT16, 14DT03, 14DT13, 14DT19, 14DT20, 14DT24, 14DT25, 14ET05, 14ET23, 14ET28, 14FT04, 14FT13, 14FT20, 14GT03, 14GT18, 14HT03, 14HT09, 14HT12, 14HT17, 14IT08, 14IT17, 14JT21, 14JT24; Product Code 116200-000390 Batch Number 13FT12, 13FT18, 13GE28J, 13GT16, 13GT29, 13HT12, 13IT05, 13IT10, 13IT13, 13IT20, 13IT20R, 13JT05R, 13JT08, 13JT15, 13JT20R, 13KT05, 13KT18, 13LT08, 14BT15, 14BT16, 14BT21, 14CT11, 14CT16, 14DT13, 14DT15, 14ET04, 14ET10, 14FT04, 14FT16, 14GT03, 14GT15, 14GT21, 14HT03, 14HT17, 14HT23, 14IT05, 14IT08, 14IT17, 14IT20, 14JT12, 14JT24; Product Code 116200-000410 Batch Number 13FT12, 13GE30J, 13GT11, 13GT24, 13GT29, 13HT12, 13HT17, 13IT10, 13IT13, 13IT20R, 13JT05, 13JT05R, 13JT20, 13KT05, 13KT12, 13LT04, 13LT08, 14AT08, 14BT21, 14CT11, 14DT13, 14DT15, 14DT19, 14DT24, 14ET04, 14ET05, 14ET22, 14FT13, 14GT15, 14GT21, 14HT03, 14HT09, 14HT17, 14HT20, 14HT23, 14IT08

Lot Numbers:
162000260
Number
116200280
Number
116200350
Number
116200370
Number
116200390
Number
116200410
Number
116201350
Number
116201410
Number
116200-000260
Number
116200-000260
Number
116200-000280
Number
116200-000350
Number
116200-000370
Number
116200-000390
Number
116200-000410
Number
Product: Bronchial One Lumen Tube - Left

Product Code 115900-000065 Batch Number 13FT06, 13GT24, 13JT08, 13KT12, 13LT08, 14AT20, 14DT19, 14ET04, 14GT10, 14GT15, 14IT11, 14JT09, 14JT24; Product Code 115900-000080 Batch Number 13FT17, 13IT11, 13KT05, 13KT12, 14AT04, 14BT04, 14BT15, 14DT19, 14ET04, 14ET22, 14GT15, 14GT18, 14IT14, 14JT09, 14JT18

Lot Numbers:
115900-000065
Number
115900-000080
Number
Product: Bronchial One Lumen Tube - Right

Product Code 115901-000065 Batch Number 13FT06, 13IT05, 13JT08, 13KT12, 14CT11, 14DT03, 14DT24, 14ET04, 14FT04, 14FT20, 14GT10; Product Code 115901-000080 - Batch Number 13GT16, 13KT18, 13LT08, 14CT11, 14DT03, 14DT24, 14GT15, 14HT12, 14HT20, 14JT04, 14JT12, 14JT21

Lot Numbers:
115901-000065
Number
115901-000080
Number
Product: Carlens Bronchial Double Lumen Tube Set (Left) Sterile

Product Code 116101370  Batch Number 13KT12, 13LT04; Product Code 116101390  Batch Number 13KT18; Product Code 116101410  Batch Number 13FT12R, 13GT05, 13JT11, 13JT15; Product Code 116101-000350  Batch Numbers 14JT14; Product Code 116101-000370  Batch Numbers 13FT06, 13FT12, 13FT18, 13GT05, 13GT29, 13HT07, 13HT12, 13HT17, 13IT16, 13IT20R, 13JT08, 13JT21, 13KT12, 13KT18, 13LT04, 13LT14, 14AT08, 14BT14, 14BT15, 14CT11, 14CT16, 14DT10, 14DT15, 14DT19, 14DT24, 14ET10, 14ET11, 14ET22, 14FT04, 14FT05, 14FT10, 14FT13, 14GT10, 14GT11, 14GT15, 14GT21, 14HT17, 14IT05, 14IT11, 14JT09, 14JT14; Product Code 116101-000390  Batch Numbers 13FT06, 13FT12, 13GT05, 13GT23, 13GT29, 13HE35, 13HT17, 13IT05, 13IT16, 13IT20, 13IT20R, 13JT08, 13JT21, 13KT12, 13KT15, 13KT18, 13LT04, 13LT11, 14BT14, 14BT21, 14CT11, 14CT21, 14DT03, 14DT13, 14DT15, 14DT19, 14DT20, 14DT25, 14ET04, 14ET28, 14FT04, 14FT16, 14GT10, 14GT11, 14GT21, 14GT23R, 14HT17, 14HT23, 14HT24, 14IT08, 14JT09, 14JT12; Product Code 116101-000410 - Batch Number 13FT06, 13FT12, 13GT05, 13GT24, 13GT29, 13HT07, 13HT12, 13HT17, 13IT16, 13IT20R, 13JT08, 13JT11, 13JT15, 13JT21, 13KT12, 13KT15, 13KT23, 13LT08, 13LT14, 13LT18, 14AT20, 14BT21, 14CT11, 14CT16, 14CT20, 14DT13, 14DT19, 14ET05, 14ET10, 14ET28, 14FT13, 14FT16, 14GT15, 14GT18, 14GT21R, 14HT03, 14HT17, 14HT23, 14HT24, 14JT09

Lot Numbers:
116101370
Number
116101390
Number
116101410
Number
116101-000350
Numbers
116101-000370
Numbers
116101-000390
Numbers
116101-000410
Number
Product: Tracheopart Set (Left), Sterile

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

Lot Numbers:
116400-000750
Number
116400-000850
Number
116400-000950
Number
Product: Tracheopart Set (Right), Sterile

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

Lot Numbers:
116401-000750
Number
116401-000850
Number
116401-000950
Number
Product: White Bronchial Double Lumen Tube Set (Right) Sterile

Product Code 116201-000350 Batch Number 13FT17, 13GT05, 13GT24, 13HT07, 13HT12, 13HT17, 13IT16, 13IT20, 13JT20, 13JT21, 13JT25R, 13KT05, 13KT05R, 13KT12, 13KT23, 13LT08, 14CT06, 14CT11, 14CT20, 14DT03, 14DT06, 14DT19, 14ET10, 14ET23, 14ET28, 14FT04, 14FT05, 14FT13, 14FT16, 14GT18, 14GT21, 14HT03, 14HT17, 14HT24, 14IT08, 14JT14, 14JT21; Product Code 116201-000370 Batch Number 13FT06, 13GT11, 13GT29, 13HT12, 13HT17, 13IT10, 13IT16, 13IT20R, 13JT08, 13JT20, 13JT25, 13KT05, 13KT12, 13KT23, 13LT08, 13LT11, 14AT08, 14CT06, 14CT11, 14CT20, 14DT19, 14DT24, 14ET04, 14ET10, 14ET22, 14ET23, 14FT04, 14FT13, 14GT18, 14GT21, 14HT03, 14HT20, 14HT23, 14IT05, 14IT08, 14JT14, 14JT18; Product Code 116201-000390 Batch Number 13FT06, 13GT11, 13HT07, 13HT12, 13IT10, 13IT16, 13IT20, 13IT20R, 13JT08, 13JT08R, 13JT20, 13JT21, 13KT12, 13KT18, 14BT16, 14CT06, 14CT16, 14CT20, 14DT03, 14DT13, 14DT24, 14ET10, 14ET23, 14ET28, 14FT13, 14FT16, 14GT05, 14GT18, 14GT21, 14HT03, 14HT09, 14HT20, 14HT23, 14IT08, 14IT14; Product Code 116201-000410 Batch Number 13IT20, 13JT25R, 13KT05R, 13KT12, 13KT15, 13KT18, 13LT11, 14AT08, 14CT11, 14CT16, 14CT21, 14DT13, 14DT19, 14ET04, 14ET22, 14ET28, 14GT18, 14HT03, 14HT17, 14JT12

Lot Numbers:
116201-000350
Number
116201-000370
Number
116201-000390
Number
116201-000410
Number
Product: Bronchial Double Lumen Tube Set (Left), Extra Length, Sterile

Product Code 116164-000390  Batch Number 14BT21

Lot Numbers:
116164-000390
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 71727
Status: Resolved
Manufacturer: Teleflex, Inc.
Manufactured In: United States
Units Affected: 6,991 ea. - US & 136,759 ea. - INTL

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.