The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2411-2015·Announced 2015-08-26

Teleflex Recalls Carlens Bronchial Double Lumen Tube Sets Due to Connector Detachment

Teleflex is recalling Carlens 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 medical device defect (connector detachment) that poses a risk of harm, although no specific injuries or illnesses are reported in the source text.

Plain-English summary

Teleflex, Inc. is recalling Carlens Bronchial Double Lumen Tube Set (Left) Sterile products. The recall was initiated following customer complaints that the cobb connector detached from the main connector prior to use.

The affected products were distributed in numerous U.S. states, including Alabama, Alaska, Arizona, California, and others, as well as in Washington D.C., Puerto Rico, Canada, and several international locations including Bolivia, Ecuador, Hong Kong, Malaysia, the Philippines, Taiwan, and Trinidad & Tobago. Specific product codes and batch numbers are listed in the official recall documentation.

Healthcare providers and facilities should stop using the affected devices and contact Teleflex for instructions on how to return or replace the products.

The recalled product

Product
Carlens Bronchial Double Lumen Tube Set (Left) Sterile
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 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
  • 13GT29
  • 13HT07
  • 13HT12
  • 13HT17
  • 13IT16
  • 13IT20R
  • 13JT08
  • 13JT21
  • 13KT12

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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