The Recall Desk
SevereFDA (Devices)·Z-1949-2023·Announced 2023-07-05

Teleflex Preformed AGT Endotracheal Tubes Recalled for Connector Disconnection

Teleflex is recalling 670 units of Preformed AGT Oral Endotracheal Tubes nationwide due to reports of 15mm connector disconnection from the tube.

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. No deaths, injuries, or hospitalizations have been reported; however, the connector disconnection defect in an endotracheal tube presents a potential hazard to airway management.

Plain-English summary

Teleflex LLC is recalling 670 units of the Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff (REF 111780085), distributed nationwide including Puerto Rico.

The recall was issued due to reports of disconnection of the 15mm connector from the endotracheal tube. The FDA classified this as a Class I recall. Affected units are identified by UDI/DI 14026704341136 and batch numbers: 18GG25, 18LG18, 19AG19, 19DT36, 20CT32, 20GT34, KME21B2675, KME21F0887, and KME22H1797.

Healthcare facilities and medical providers should identify affected units in their inventory using the UDI/DI and batch numbers provided. For instructions on returns, replacements, or other guidance, contact Teleflex LLC or the FDA. The FDA recall number is Z-1949-2023.

The recalled product

Product
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780085
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management Equipment
Hazard
Affected units
670

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 (10)

  • UDI/DI 14026704341136
  • Batch Numbers: 18GG25
  • 18LG18
  • 19AG19
  • 19DT36
  • 20CT32
  • 20GT34
  • KME21B2675
  • KME21F0887
  • KME22H1797

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 123 recalled by TELEFLEX LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 123 products in this recall →

Related recalls

Same manufacturer · TELEFLEX LLC

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Same hazard · connector disconnection

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