The Recall Desk
SevereFDA (Devices)·Z-1944-2023·Announced 2023-07-05

Endotracheal Tube Connector Disconnection Recalls 14,480 Units

Teleflex is recalling 14,480 Preformed AGT Oral Endotracheal Tubes nationwide due to reports of 15mm connector disconnection from the tube during use.

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: This recall is classified as FDA Class I. According to the severity rubric, FDA Class I recalls require a minimum score of 4. Connector disconnection from an endotracheal tube during use presents a serious hazard.

Plain-English summary

Teleflex LLC is recalling 14,480 Preformed AGT Oral Endotracheal Tubes with Murphy Eye, High Volume, Low Pressure Cuff (REF 111780055). These tubes were distributed nationwide in the United States, including Puerto Rico, and are identified by UDI/DI 14026704341075 with multiple batch numbers ranging from 18FG23 to KME23A3176.

The recall was initiated because reports indicate that the 15mm connector can disconnect from the endotracheal tube during use.

Healthcare facilities and providers should immediately discontinue use of the affected units and contact Teleflex for replacement or disposal instructions.

The recalled product

Product
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780055
Manufacturer
TELEFLEX LLC
Hazard
  • connector-disconnection

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 14026704341075
  • Batch Numbers: 18FG23
  • 18FG24
  • 18GG03
  • 18GT26
  • 18IT05
  • 18IT06
  • 18JG36
  • 18KG08
  • 18KG34
  • 18KG44
  • 18LG11
  • 18LG31
  • 19AG21
  • 19AG36
  • 19CT36
  • 19DT06
  • 19FT18
  • 19HT80
  • 19LT04

Distribution

Distributed nationwide across the United States.