The Recall Desk
SevereFDA (Devices)·Z-1964-2023·Announced 2023-07-05

Endotracheal tubes recalled for 15mm connector disconnection risk

TELEFLEX LLC is recalling 1,280 endotracheal tubes due to reports of 15mm connector disconnection. The defect could compromise airway management and poses serious safety risks during medical procedures.

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 classification indicates a serious hazard. The connector disconnection of a critical airway management device could prevent proper ventilation during anesthesia or emergency procedures, creating life-threatening risks. No injuries have been reported in the source.

Plain-English summary

TELEFLEX LLC is recalling 1,280 units of an endotracheal tube product (High Volume, Low Pressure Cuff, REF 112080085) with US nationwide distribution including Puerto Rico.

The recalled endotracheal tubes are manufactured under the following batch numbers: 18IG19, 18KG26, 19CT61, 19GT31, 19JT19, 19KT38, 19LT17, 20CT02, 20DT23, 20ET17, 20GT57, and KME22A1989. These tubes have been reported to have a defect in which the 15mm connector may disconnect from the endotracheal tube.

Disconnection of the 15mm connector during use could prevent proper airway management and patient ventilation. The endotracheal tube is a critical device for maintaining airways during anesthesia and emergency medical procedures, making this connector defect a serious safety concern.

Healthcare facilities and medical professionals with affected inventory should verify their stock against the identified batch numbers. Affected units should not be used for patient care. Contact the manufacturer for replacement product or other guidance regarding the recalled units.

The recalled product

Product
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080085
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 (13)

  • UDI/DI 14026704341266
  • Batch Numbers: 18IG19
  • 18KG26
  • 19CT61
  • 19GT31
  • 19JT19
  • 19KT38
  • 19LT17
  • 20CT02
  • 20DT23
  • 20ET17
  • 20GT57
  • KME22A1989

Distribution

Distributed nationwide across the United States.