The Recall Desk
SevereFDA (Devices)·Z-1941-2023·Announced 2023-07-05

Endotracheal Tube Connector Disconnection Recall Due to Device Malfunction

Teleflex is recalling 20,042 endotracheal tubes due to reports of 15mm connector disconnection that could compromise airway management. The FDA classified this as a Class I recall.

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: The FDA classified this as a Class I recall for a medical device malfunction. Per the severity rubric, FDA Class I recalls are never scored below 4. Although no illnesses or injuries have been reported, the classification reflects the serious potential harm from connector disconnection during critical airway management procedures.

Plain-English summary

Teleflex LLC is recalling 20,042 units of the Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff (model REF 111780040) due to reports of connector disconnection. The affected products were distributed nationwide throughout the United States and Puerto Rico.

The company has received reports that the 15mm connector may disconnect from the endotracheal tube during use. This malfunction could compromise airway management and disrupt oxygen delivery during patient care.

The FDA classified this as a Class I recall, indicating the device malfunction presents a serious hazard. Affected batch numbers include 18FG24, 18GG03, 18GG04, 18GG24, 18GT26, 18HG24, 18JG07, 18KG22, 18KG34, 18LG33, and others. The UDI/DI code is 14026704341044.

The recalled product

Product
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780040
Manufacturer
TELEFLEX LLC
Hazard
  • connector-failure
  • device-malfunction

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 14026704341044
  • Batch Numbers: 18FG24
  • 18GG03
  • 18GG04
  • 18GG24
  • 18GT26
  • 18HG24
  • 18JG07
  • 18KG22
  • 18KG34
  • 18LG33
  • 19AG36
  • 19BG12
  • 19CG07
  • 19CT69
  • 19DT42
  • 19ET58
  • 19FT18
  • 19GT43
  • 19GT44

Distribution

Distributed nationwide across the United States.