The Recall Desk
SevereFDA (Devices)·Z-1952-2023·Announced 2023-07-05

FDA Recalls Teleflex Endotracheal Tubes for Connector Disconnection

The FDA is recalling approximately 302,652 Teleflex preformed oral endotracheal tubes nationwide due to reports of disconnection between the 15mm connector and the tube. Healthcare providers should immediately discontinue use of affected units.

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 is an FDA Class I recall, which requires a minimum severity of Severe (score 4). Although no illnesses or injuries are reported in the source, the potential for device failure in a critical airway management device poses significant risk.

Plain-English summary

Teleflex LLC is recalling approximately 302,652 units of Preformed AGT Oral Endotracheal Tubes (REF 111781050) distributed nationwide, including Puerto Rico.

The FDA classified this as a Class I recall due to reports of disconnection of the 15mm connector from the endotracheal tube. The 15mm connector secures the tube to other medical equipment during use.

Healthcare providers should immediately cease using affected units identified by batch numbers and UDI 14026704341181. Report any instances of connector disconnection to Teleflex LLC or the FDA.

The recalled product

Product
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781050
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 14026704341181
  • Batch Numbers: 18FG31
  • 18FT35
  • 18FT39
  • 18GG17
  • 18GG18
  • 18GT32
  • 18HG17
  • 18HG19
  • 18HG21
  • 18HG22
  • 18HG29
  • 18IG15
  • 18IG17
  • 18IG30
  • 18JG16
  • 18JG19
  • 18JG35
  • 18JG37
  • 18KG17

Distribution

Distributed nationwide across the United States.