The Recall Desk
SevereFDA (Devices)·Z-1881-2023·Announced 2023-07-05

Endotracheal Tubes Recalled for 15mm Connector Disconnection

TELEFLEX LLC recalls 2,520 endotracheal tubes (model REF 112080055) due to reports of 15mm connector disconnection. The disconnection could compromise airway function during critical care use.

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 mandates a minimum severity score of 4 per the rubric. Disconnection of a critical airway management device connector poses significant risk to patient safety, even though no illnesses or injuries have been reported in the source text.

Plain-English summary

TELEFLEX LLC is recalling 2,520 endotracheal tubes with model reference 112080055, which feature a high-volume, low-pressure cuff design for oral or nasal insertion. The affected units span multiple batch numbers and were distributed nationwide in the United States, including Puerto Rico.

The company has received reports of disconnection of the 15mm connector from the affected endotracheal tubes. A disconnection of this connector could compromise the proper function and seal of the airway device during use.

This recall applies to healthcare providers and medical facilities that received units from the identified batch numbers.

Healthcare providers should immediately discontinue use of affected units and contact TELEFLEX LLC for replacement devices or further instructions regarding the recalled batch numbers.

The recalled product

Product
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080055
Manufacturer
TELEFLEX LLC
Hazard
  • connector-disconnection
  • airway-compromise

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 (18)

  • UDI/DI 14026704341266
  • Batch Numbers: 18FG02
  • 18IG29
  • 18KG28
  • 19AG39
  • 19BG02
  • 19CT64
  • 19GT31
  • 19IT33
  • 20DT18
  • KME20G0435
  • KME20K2579
  • KME21K0764
  • KME21K1278
  • KME22B0079
  • KME22B0080
  • KME22E2802
  • KME22H2250

Distribution

Distributed nationwide across the United States.