The Recall Desk
HighFDA (Devices)·Z-2409-2015·Announced 2015-08-26

Teleflex Recalls Bronchial One Lumen Tubes Due to Connector Detachment

Teleflex is recalling Bronchial One Lumen Tubes - Left because customer complaints reported the cobb connector detaching from the main connector prior to use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a mechanical defect (connector detachment) that poses a risk of harm during use, but the source text does not report any injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Teleflex, Inc. is recalling Bronchial One Lumen Tubes - Left (Product Codes 115900-000065 and 115900-000080) due to customer complaints. The complaints reported that the cobb connector detached from the main connector prior to use.

The affected products are distributed across numerous US states, DC, Puerto Rico, and several international locations including Canada, Bolivia, Ecuador, Hong Kong, Malaysia, Philippines, Taiwan, and Trinidad & Tobago. Specific batch numbers are listed in the structured product information.

The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled devices, nor does it report any injuries or illnesses associated with the defect.

The recalled product

Product
Bronchial One Lumen Tube - Left
Manufacturer
Teleflex, Inc.
Category
Medical Device — Airway Management
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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
  • 14AT04
  • 14BT04
  • 14BT15
  • 14ET22

Distribution

Distributed in 40 states:

Part of a larger recall action

This product is one of 9 recalled by Teleflex, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Related recalls

Same manufacturer · Teleflex, Inc.

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Same hazard · mechanical failure

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