The Recall Desk
SevereFDA (Devices)·Z-1870-2023·Announced 2023-07-05

Preformed AGT Oral Endotracheal Tubes recalled for connector disconnection risk

TELEFLEX is recalling 2,874 Preformed AGT Oral Endotracheal Tubes nationwide due to reports of the 15mm connector disconnecting from the tube. Affected users should immediately discontinue 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: The FDA classified this as a Class I recall, the agency's most serious medical device recall classification. Although no specific injuries are reported in the source text, connector disconnection from an endotracheal tube during surgery or critical care could result in airway compromise and serious patient harm.

Plain-English summary

TELEFLEX LLC is recalling approximately 2,874 Preformed AGT Oral Endotracheal Tubes (uncuffed/plain - Murphy model, REF 100181030) due to reports of disconnection of the 15mm connector from the endotracheal tube.

The recalled tubes were distributed nationwide in the United States and Puerto Rico. Affected batch numbers include 18GG23, 18HG17, 18HG21, 18IG17, 18LG18, 19AG25, 19BG19, 19BG32, 19GT16, 19IT53, 19LT21, KME22F2174, and KME22G1753.

Endotracheal tubes are used to maintain open airways during surgery and critical care. A disconnected connector could compromise the airway, presenting a serious patient safety risk. This recall is classified as FDA Class I, the agency's most serious medical device recall classification.

Healthcare facilities and individuals who have received these tubes should immediately remove them from use and consider returning them to TELEFLEX or reporting the issue to the FDA if the tubes have already been used.

The recalled product

Product
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181030
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 (14)

  • UDI/DI 14026704340528
  • Batch Numbers: 18GG23
  • 18HG17
  • 18HG21
  • 18IG17
  • 18LG18
  • 19AG25
  • 19BG19
  • 19BG32
  • 19GT16
  • 19IT53
  • 19LT21
  • KME22F2174
  • KME22G1753

Distribution

Distributed nationwide across the United States.