The Recall Desk
SevereFDA (Devices)·Z-1954-2023·Announced 2023-07-05

Preformed AGT Endotracheal Tubes Recalled for Connector Disconnection Risk

TELEFLEX is recalling approximately 43,571 units of Preformed AGT Oral Endotracheal Tubes due to reports of 15mm connector disconnection from the tube, affecting nationwide distribution including Puerto Rico.

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 classified this as a Class I recall of a critical airway management device. Per FDA guidelines, Class I recalls require a minimum score of 4. Connector disconnection poses an immediate risk to patient airway patency and ventilation during use.

Plain-English summary

TELEFLEX LLC is recalling approximately 43,571 units of Preformed AGT Oral Endotracheal Tubes with Murphy Eye, High Volume, Low Pressure Cuff (Reference 111781060). The affected units are distributed nationwide, including Puerto Rico.

The recall addresses reports of disconnection of the 15mm connector from the endotracheal tube. Disconnection during patient use could compromise airway patency and patient ventilation.

Healthcare providers and facilities using affected units should stop use immediately. Affected units can be identified by UDI/DI 14026704341204 and the batch numbers listed in the FDA recall notice. Contact TELEFLEX or your healthcare provider for replacement units.

The recalled product

Product
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781060
Manufacturer
TELEFLEX LLC
Hazard
  • connector-disconnection
  • airway-loss

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 14026704341204
  • Batch Numbers: 18FT39
  • 18GT32
  • 18HG19
  • 18IG10
  • 18IG16
  • 18IG30
  • 18JG35
  • 18LG15
  • 18LG30
  • 19AG15
  • 19AG25
  • 19CT33
  • 19CT36
  • 19DT35
  • 19DT46
  • 19ET34
  • 19ET69
  • 19FT01
  • 19GT13

Distribution

Distributed nationwide across the United States.