The Recall Desk
SevereFDA (Devices)·Z-1892-2023·Announced 2023-07-05

Endotracheal tube connector may disconnect during patient use

Teleflex is recalling endotracheal tubes due to reports of 15mm connector disconnection. The FDA Class I recall affects approximately 30,423 units 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 medical device classification per agency designation. Connector failure during use poses a threat to patients dependent on mechanical ventilation.

Plain-English summary

Teleflex LLC is recalling its Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff devices (product code REF 112082090). These tubes are breathing tubes used in hospitalized and critically ill patients requiring mechanical ventilation.

The FDA has classified this as a Class I recall due to reports of disconnection of the 15mm connector from the endotracheal tube. This connector joins the tube to ventilator equipment, and its disconnection could interrupt patient ventilation.

Approximately 30,423 units have been distributed throughout the United States, including Puerto Rico. Multiple production batches have been identified as affected and are listed with the FDA.

The recalled product

Product
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082090
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 14026704341464
  • Batch Numbers: 18FG23
  • 18FT17
  • 18FT24
  • 18FT25
  • 18FT49
  • 18GG12
  • 18GG26
  • 18JG38
  • 18KG04
  • 18KG05
  • 18KG23
  • 18KG26
  • 18KG38
  • 18KT04
  • 18KT27
  • 18LG13
  • 19AT19
  • 19CG02
  • 19ET11

Distribution

Distributed nationwide across the United States.