The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2408-2015·Announced 2015-08-26

Teleflex Recalls Bronchial Double Lumen Tube Sets Due to Connector Detachment

Teleflex is recalling specific batches 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 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard involves a mechanical defect (connector detachment) prior to use, which is a significant quality issue but does not involve reported injuries or high-risk pathogens.

Plain-English summary

Teleflex, Inc. is recalling specific batches of Bronchial Double Lumen Tube Set (Right), Sterile. The recall is being conducted due to customer complaints reporting that the cobb connector detached from the main connector prior to use.

The affected products are distributed across numerous U.S. states, including Alabama, Alaska, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, and the District of Columbia. The products were also distributed to Puerto Rico, Canada, Bolivia, Ecuador, Hong Kong, Malaysia, the Philippines, Taiwan, and Trinidad & Tobago.

The recall includes multiple product codes and batch numbers, such as Product Code 162000260 (Batch 14CT11) and Product Code 116200280 (Batches 13JT05, 13KT18, 14CT11, 14FT05, 14FT10). Additional affected codes include 116200350, 116200370, 116200390, 116200410, 116201350, 116201410, and 116200-000260 through 116200-000410, with various associated batch numbers listed in the official recall notice. Healthcare facilities and distributors should check their inventory against these specific codes and batch numbers to identify affected units.

The recalled product

Product
Bronchial Double Lumen Tube Set (Right), 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 162000260 Batch Number 14CT11
  • Product Code 116200280 Batch Number 13JT05
  • 13KT18
  • 14CT11
  • 14FT05
  • 14FT10
  • Product Code 116200350 Batch Number 13FT12R
  • 13GT11
  • 13HT07
  • 13KT23
  • 14AT08
  • Product Code 116200370 Batch Number 13KT23
  • 13LT14
  • 14DT25
  • 14ET23
  • Product Code 116200390 Batch Number 13HT12
  • 13JT08
  • 14ET10
  • Product Code 116200410 Batch Number 14ET05
  • 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 →

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