The Recall Desk
SevereFDA (Devices)·Z-1875-2023·Announced 2023-07-05

Endotracheal Tubes Recalled for 15mm Connector Disconnection

TELEFLEX is recalling approximately 25,435 endotracheal tubes (REF 100382035) distributed nationwide due to reported disconnection of the 15mm connector from the device.

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 is the most serious classification for medical devices. Although the source does not report deaths, injuries, or hospitalizations, the Class I designation reflects significant health hazards associated with the 15mm connector disconnection defect in a critical airway management device.

Plain-English summary

TELEFLEX LLC is recalling endotracheal tubes with an oral/nasal uncuffed/plain Murphy design (REF 100382035). Approximately 25,435 units of this device were distributed to healthcare facilities nationwide, including Puerto Rico.

The recall was prompted by reports of disconnection of the 15mm connector from the endotracheal tube during use. This connector is the interface point between the tube and other airway management components.

The affected batch numbers and lot identifiers are specified in the official FDA recall notice. Healthcare facilities that received these products should verify whether any affected units remain in their inventory.

Further information and guidance regarding the recalled devices is available from TELEFLEX LLC and the U.S. Food and Drug Administration.

The recalled product

Product
Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382035
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 14026704340801
  • Batch Numbers: 18GG15
  • 18GT32
  • 18IG13
  • 18KG24
  • 18KG33
  • 18KG34
  • 18LG01
  • 18LG03
  • 19CG05
  • 19CT36
  • 19CT72
  • 19DT13
  • 19KT20
  • 20AT05
  • 20AT50
  • 20BG19
  • 20BT43
  • 20DT01
  • 20DT04

Distribution

Distributed nationwide across the United States.