The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2415-2015·Announced 2015-08-26

Teleflex Recalls Bronchial Double Lumen Tube Sets Due to Connector Detachment

Teleflex is recalling specific lots of Bronchial Double Lumen Tube Sets because the cobb connector may detach from the main connector before use.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 is classified as FDA Class II, and the hazard involves a mechanical failure of a medical device component prior to use, which poses a risk of harm but has no reported injuries or illnesses in the source text.

Plain-English summary

Teleflex, Inc. is recalling the Bronchial Double Lumen Tube Set (Left), Extra Length, Sterile. The recall is due to customer complaints that the cobb connector detached from the main connector prior to use.

The affected product is identified by Product Code 116164-000390 and Batch Number 14BT21. The recall is classified as Class II by the U.S. Food and Drug Administration.

The product was distributed to facilities in numerous U.S. states, Washington D.C., Puerto Rico, and several international locations including Canada, Bolivia, Ecuador, Hong Kong, Malaysia, the Philippines, Taiwan, and Trinidad & Tobago. Healthcare facilities should stop using the affected units and contact Teleflex for instructions on return or replacement.

The recalled product

Product
Bronchial Double Lumen Tube Set (Left), Extra Length, Sterile
Manufacturer
Teleflex, Inc.
Category
Medical Device — Respiratory
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 (1)

  • Product Code 116164-000390  Batch Number 14BT21

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 →

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