The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1945-2023·Announced 2023-07-05

Endotracheal Tube Connector Disconnection Recall: TELEFLEX Preformed AGT

TELEFLEX is recalling 16,570 units of Preformed AGT Oral Endotracheal Tubes due to reports of 15mm connector disconnection, which could compromise airway management during use.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification applies. The connector disconnection defect on a critical airway management device warrants this highest classification level despite no reported patient harm in the source material.

Plain-English summary

TELEFLEX LLC is recalling 16,570 units of Preformed AGT Oral Endotracheal Tubes (Murphy Eye, High Volume, Low Pressure Cuff, REF 111780060) distributed nationwide in the United States and Puerto Rico.

Reports have been received of disconnection of the 15mm connector from the affected endotracheal tubes. These tubes are used for airway management in patients under anesthesia and in critical care settings.

The affected batch numbers are: 18FG12, 18FG23, 18GG03, 18GT26, 18HG24, 18JG14, 18KG08, 18KG22, 18LG31, 19AG09, 19AG11, 19AG21, 19DT42, 19ET34, 19FT18, 19GT44, 19HT66, 19JT01, 19JT20, 19KT17, 19LT04, 19LT08, 19LT31, 19LT32, 20AT09, 20CT23, 20DT29, KME20L1712, and KME20M0352. The Universal Device Identifier (UDI/DI) is 14026704341082.

The recalled product

Product
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780060
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management
Hazard
Affected units
16,570

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 14026704341082
  • Batch Numbers: 18FG12
  • 18FG23
  • 18GG03
  • 18GT26
  • 18HG24
  • 18JG14
  • 18KG08
  • 18KG22
  • 18LG31
  • 19AG09
  • 19AG11
  • 19AG21
  • 19DT42
  • 19ET34
  • 19FT18
  • 19GT44
  • 19HT66
  • 19JT01
  • 19JT20

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 →

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