The Recall Desk
SevereFDA (Devices)·Z-1868-2023·Announced 2023-07-05

TELEFLEX Preformed Endotracheal Tube Recall for Connector Disconnection Risk

TELEFLEX is recalling 1,570 units of Preformed AGT Oral Endotracheal Tubes nationwide due to reports of 15mm connector disconnection from the tubes. The disconnection could compromise airway management during patient ventilation.

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 establishes a minimum severity of 4. While no deaths or injuries have been reported, the defect (connector disconnection) in a critical airway management device poses serious risk of patient harm through loss of ventilation support.

Plain-English summary

TELEFLEX LLC is recalling 1,570 units of Preformed AGT Oral Endotracheal Tubes (uncuffed, plain, Murphy brand, REF 100180065) distributed nationwide, including Puerto Rico. The 15mm connector on the endotracheal tube may disconnect from the tube during use.

An endotracheal tube is a critical airway management device used to maintain a patient's airway during anesthesia or mechanical ventilation. Disconnection of the connector during patient care could result in loss of airway support and ventilation.

The affected batches are: 18JG07, 19AG21, 19BG12, 19HT03, 19HT34, 19JT02, 19LT32, 20AT49, KME20M2642, KME21B0078, KME22D1517, KME22H1720, and KME22J0807. Products are identifiable by UDI/DI 14026704340504.

Healthcare facilities and clinicians using the affected devices should verify that connectors are fully seated and secure before patient use, and should contact TELEFLEX for instructions regarding return or replacement.

The recalled product

Product
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180065
Manufacturer
TELEFLEX LLC
Hazard
  • connector-failure

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 14026704340504
  • Batch Numbers: 18JG07
  • 19AG21
  • 19BG12
  • 19HT03
  • 19HT34
  • 19JT02
  • 19LT32
  • 20AT49
  • KME20M2642
  • KME21B0078
  • KME22D1517
  • KME22H1720
  • KME22J0807

Distribution

Distributed nationwide across the United States.