The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2407-2015·Announced 2015-08-26

Teleflex Recalls Bronchial Double Lumen Tube Sets Due to Connector Detachment

Teleflex is recalling sterile 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a mechanical defect (connector detachment) with no reported injuries or illnesses, fitting the criteria for a moderate severity recall involving a risk of harm where injury has not yet been reported or a voluntary precautionary recall.

Plain-English summary

Teleflex, Inc. is recalling sterile Bronchial Double Lumen Tube Sets (Left) due to customer complaints that the cobb connector detached from the main connector prior to use. The recall involves specific product codes and batch numbers distributed across the United States, Puerto Rico, and several international locations.

The affected products are identified by specific product codes and batch numbers listed in the recall documentation. The issue is a mechanical defect where a component detaches before the device is used on a patient. No injuries or illnesses have been reported in the source text.

Healthcare facilities and consumers should stop using the affected products and contact Teleflex for instructions on return or replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Bronchial Double Lumen Tube Set (Left), Sterile
Manufacturer
Teleflex, Inc.
Category
Medical Device — Respiratory / 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 116100260  Batch Number 13GT24
  • 13HT07
  • 13IT16
  • 13KT23
  • 14AT08
  • 14DT19
  • 14ET10
  • 14ET11
  • 14FT04
  • 14FT10
  • 14GT03
  • Product Code 116100280  Batch Number 13GT24
  • 13KT05
  • 14AT12
  • 14ET23
  • Product Code 116100350  Batch Number 13GT24
  • 13JT08
  • 13KT18
  • 13LT14
  • 14CT06

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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