The Recall Desk
SevereFDA (Devices)·Z-1929-2023·Announced 2023-07-05

Endotracheal Tube Connector Disconnection Risk - Teleflex Magill Recall

TELEFLEX LLC is recalling 3,031 Endotracheal Tube units due to reports of 15mm connector disconnection. The affected Magill model (REF 100380045) was distributed nationwide.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification indicates the most serious category of medical device recall. Connector disconnection on an airway device poses serious risk of loss of airway control and inadequate ventilation during medical procedures.

Plain-English summary

TELEFLEX LLC is recalling 3,031 units of Endotracheal Tube oral/nasal uncuffed plain (Magill model, REF 100380045) distributed nationwide, including Puerto Rico.

The 15mm connector can disconnect from the endotracheal tube, potentially impairing airway management during medical procedures.

The affected batch numbers are: 18FG22, 18GT16, 18IG04, 18JG08, 19CT42, 19HT05, 19HT61, 19JT51, 19KT13, 20DT04, KME20J0756, KME20K2144, KME20L0425, KME21A2196, KME21A3268, KME21C0914, KME22D0877, KME22E0896, KME22F1601, KME22G1456, and KME22G2369. The UDI/DI is 14026704340658.

Healthcare facilities should identify affected units in their inventory and contact TELEFLEX LLC for replacement or further instructions.

The recalled product

Product
Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380045
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management
Hazard
Affected units
3,031

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)

  • UDI/DI 14026704340658
  • Batch Numbers: 18FG22
  • 18GT16
  • 18IG04
  • 18JG08
  • 19CT42
  • 19HT05
  • 19HT61
  • 19JT51
  • 19KT13
  • 20DT04
  • KME20J0756
  • KME20K2144
  • KME20L0425
  • KME21A2196
  • KME21A3268
  • KME21C0914
  • KME22D0877
  • KME22E0896
  • KME22F1601

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 123 recalled by TELEFLEX LLC 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 123 products in this recall →

Related recalls

Same manufacturer · TELEFLEX LLC

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Same hazard · connector disconnection

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