The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2414-2015·Announced 2015-08-26

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

Teleflex, Inc. is recalling White Bronchial Double Lumen Tube Sets (Right) Sterile because the cobb connector may detach from the main connector prior to 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 involves a mechanical defect (connector detachment) prior to use, which poses a risk of harm but does not meet the criteria for Severe (Class II with hospitalization) or Critical (Class I).

Plain-English summary

Teleflex, Inc. is recalling White Bronchial Double Lumen Tube Sets (Right) Sterile. The recall was initiated due to customer complaints reporting that the cobb connector detached from the main connector prior to use.

The affected products are identified by specific product codes and batch numbers listed in the official recall notice. The distribution pattern includes numerous U.S. states, the District of Columbia, Puerto Rico, and several international locations including Canada, Bolivia, Ecuador, Hong Kong, Malaysia, the Philippines, Taiwan, and Trinidad & Tobago.

Healthcare providers and consumers should stop using the affected devices and contact Teleflex, Inc. for further instructions or a replacement.

The recalled product

Product
White Bronchial Double Lumen Tube Set (Right) 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 116201-000350 Batch Number 13FT17
  • 13GT05
  • 13GT24
  • 13HT07
  • 13HT12
  • 13HT17
  • 13IT16
  • 13IT20
  • 13JT20
  • 13JT21
  • 13JT25R
  • 13KT05
  • 13KT05R
  • 13KT12
  • 13KT23
  • 13LT08
  • 14CT06
  • 14CT11
  • 14CT20
  • 14DT03

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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