The Recall Desk
SevereFDA (Devices)·Z-1894-2023·Announced 2023-07-05

Endotracheal tubes recalled for 15mm connector disconnection

Teleflex is recalling 19,250 endotracheal tubes because the 15mm connector may disconnect during use, potentially compromising airway management in patients.

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 is an FDA Class I recall of a critical airway management device. Although no deaths or injuries have been reported to date, the potential for connector disconnection during airway management constitutes a serious hazard warranting the Class I designation.

Plain-English summary

Teleflex LLC is recalling 19,250 endotracheal tubes with model reference 112082100 (oral/nasal, with Murphy eye, high-volume, low-pressure cuff). The recall covers units distributed nationwide, including Puerto Rico, with UDI/DI 14026704341488.

The recalled tubes may experience disconnection of the 15mm connector during use. This connector links the tube to ventilation equipment, and disconnection could prevent proper air delivery and compromise patient airway management.

Healthcare facilities and clinicians should identify whether they have affected units by checking the batch numbers provided in the FDA recall notice. Facilities should consider alternative products or take precautions to verify connector integrity before clinical use.

For the complete list of affected batch numbers and additional details, refer to FDA recall notice Z-1894-2023 at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-1894-2023.

The recalled product

Product
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082100
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 (20)

  • UDI/DI 14026704341488
  • Batch Numbers: 18GG13
  • 18JG24
  • 18JG36
  • 18JT06
  • 18KG10
  • 18LG06
  • 19AG36
  • 19CG02
  • 19GT16
  • 19GT59
  • 19IT33
  • 19JT56
  • 19KT14
  • 19KT49
  • 20AT01
  • 20AT22
  • 20BG18
  • 20DT18
  • 20DT19

Distribution

Distributed nationwide across the United States.