Reported Aug 26, 2015 · Terminated

Bronchial Double Lumen Tube Set (Left), Sterile

Teleflex, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Teleflex, Inc. · 550 E Swedesford Rd Ste 400 · Wayne, PA · 19087-1601

Is this the product you have?

  • Bronchial Double Lumen Tube Set (Left), Sterile
Lot codes and dates

13 of 13 products

Products covered by this recall
Model / numberProduct as published
116100260 Batch Number 13GT24, 13HT07, 13IT16, 13KT23, 14AT08, 14DT19, 14ET10, 14ET11, 14FT04, 14FT10, 14GT03
116100280 Batch Number 13GT24, 13KT05, 13KT23, 14AT12, 14ET23
116100350 Batch Number 13GT24, 13HT07, 13IT16, 13JT08, 13KT05, 13KT18, 13KT23, 13LT14, 14CT06, 14DT10, 14DT19, 14ET23
116100370 Batch Number 13GT11, 13GT24, 13HT07, 13IT16, 13JT25, 13KT23, 13LT04, 13LT18, 14CT11, 14DT13, 14DT19, 14DT24, 14DT25, 14ET10, 13ET11
116100390 Batch Number 13FT12R, 13HT07, 13IT16, 13JT11, 13JT15, 13JT25, 13KT18, 13KT23, 14AT12R, 14BT09, 14ET10, 14ET11
116100410 Batch Number 13FT12R, 13GT05, 13HT07, 13IT20, 13JT25, 13KT05, 13KT18, 13LT18, 14DT19, 14ET04, 14ET10, 14ET11, 14FT05, 14FT10
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
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
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
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
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
116100-000410Batch 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
16100-000350 Batch Number 14DE14J, 14FE24J, 14GE28J
Amount recalled
6,991 ea. - US & 136,759 ea. - INTL

This recall covers 9 products

The agency filed one notice per product. You are reading one of them; the other 8 are below.

Where it was sold

Why it was recalled

Customer complaints reporting that the cobb connector detached from the main connector prior to use.

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 15, 2017 · Data as of Sep 19, 5:22 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.