The Recall Desk
HighFDA (Devices)·Z-2413-2015·Announced 2015-08-26

Teleflex Recalls Tracheopart Sets Due to Connector Detachment

Teleflex is recalling sterile Tracheopart Sets because the cobb connector may detach from the main connector before use.

What this means for you

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 (connector detachment) in a medical device that could lead to injury, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Teleflex, Inc. is recalling sterile Tracheopart Sets (Right) due to customer complaints that the cobb connector detached from the main connector prior to use. The recall covers specific product codes and batch numbers distributed across numerous U.S. states, Puerto Rico, and several international locations.

The affected products are identified by Product Codes 116401-000750, 116401-000850, and 116401-000950, along with specific batch numbers listed in the agency's structured data. The distribution pattern includes states such as Alabama, Alaska, Arizona, California, and others, as well as countries including Canada, Bolivia, and Ecuador.

Healthcare facilities and consumers should stop using these specific Tracheopart Sets and contact Teleflex, Inc. 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
Tracheopart Set (Right), Sterile
Manufacturer
Teleflex, Inc.
Category
Medical Device — Surgical Instruments
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 116401-000750  Batch Number 13FT06
  • 13GT24
  • 13JT21
  • 13IT21R
  • 13KT23
  • 13KT23R
  • 14CT21
  • 14ET11
  • 14ET22
  • 14ET28
  • 14FT16
  • 14GT15
  • 14GT23
  • 14IT17
  • 14JT18
  • Product Code 116401-000850  Batch Number 13IT05
  • 13KT05
  • 13LT08
  • 14CT16
  • 14DT19

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 →

Related recalls

Same manufacturer · Teleflex, Inc.

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Same hazard · mechanical failure

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