The Recall Desk
CriticalFDA (Devices)·Z-1890-2023·Announced 2023-07-05

Teleflex endotracheal tubes recalled for connector disconnection defect

Teleflex LLC is recalling 170,179 endotracheal tubes nationwide due to reports of 15mm connector disconnection. The tubes are used for airway management in medical facilities.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: This is an FDA Class I recall. Per the severity rubric, FDA Class I recalls are classified as Critical. The potential for connector disconnection during airway management poses serious patient risk.

Plain-English summary

Teleflex LLC is recalling 170,179 endotracheal tubes (REF 112082080) with High Volume, Low Pressure Cuff and Murphy Eye due to reports of disconnection of the 15mm connector. These tubes are used for oral and nasal airway management in hospitals and medical facilities.

The issue involves the connector separating from the tube, which could compromise airway management during patient ventilation. The affected products were distributed nationwide, including Puerto Rico.

Healthcare facilities and medical providers using the recalled batch numbers should cease use of the affected products and contact Teleflex LLC for instructions on replacement or return. No illnesses or injuries are reported in this recall notice.

The recalled product

Product
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082080
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 14026704341440
  • Batch Numbers: 18GG11
  • 18GG12
  • 18GG13
  • 18GT08
  • 18GT11
  • 18HG40
  • 18IG04
  • 18IG07
  • 18IG12
  • 18IG13
  • 18IG23
  • 18IT06
  • 18IT10
  • 18IT16
  • 18JG07
  • 18JG09
  • 18JG13
  • 18JG26
  • 18JG37

Distribution

Distributed nationwide across the United States.