The Recall Desk
SevereFDA (Devices)·Z-1863-2023·Announced 2023-07-05

Teleflex Endotracheal Tube Connector Disconnection Recall

Teleflex is recalling Preformed AGT Oral Endotracheal Tubes due to reports that the 15mm connector may disconnect from the tube. The recall affects 5,120 units distributed nationwide.

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: This FDA Class I recall meets the minimum threshold of Severe. Per the rubric, FDA Class I classifications never go below 4. While no illnesses or injuries are explicitly reported in the source, the critical nature of endotracheal tubes and the FDA's classification support this severity level.

Plain-English summary

Teleflex LLC is recalling Preformed AGT Oral Endotracheal Tubes, uncuffed/plain Murphy type (REF 100180040), due to reports of disconnection of the 15mm connector from the endotracheal tube. The affected devices were distributed nationwide, including Puerto Rico.

Disconnection of the connector from the endotracheal tube could compromise proper airway management. This is a Class I recall issued by the FDA.

The recalled product

Product
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180040
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 (20)

  • UDI/DI 14026704340450
  • Batch Numbers: 18GT26
  • 18KG10
  • 18LG33
  • 19AG21
  • 19BG12
  • 19CT36
  • 19DT42
  • 19FT29
  • 19FT49
  • 20DT24
  • KME20L2493
  • KME20M0278
  • KME21A0061
  • KME21B1925
  • KME21M1736
  • KME22C0700
  • KME22F0734
  • KME22G0184
  • KME22H0033

Distribution

Distributed nationwide across the United States.