The Recall Desk
SevereFDA (Devices)·Z-1833-2023·Announced 2023-07-05

Teleflex Slick Set Endotracheal Tube Connector Disconnection Recall

Teleflex is recalling Slick Set Cuffed Endotracheal Tube and Stylet Sets due to reports of disconnection of the 15mm connector from the endotracheal tube. The affected units were 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 is an FDA Class I recall of a critical respiratory medical device. The agency's Class I classification mandates a minimum severity score of 4. While no reported deaths or serious injuries are mentioned in the source, the potential for airway connector disconnection during ventilation represents a significant risk to patient safety.

Plain-English summary

Teleflex LLC is recalling the Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal (REF 170080), affecting 18,150 units. An endotracheal tube is a medical device inserted into the airway to help patients breathe during surgery or critical care.

The company has received reports of disconnection of the 15mm connector from the endotracheal tube in affected units. A disconnected connector could result in loss of ventilation or inability to manage the airway during patient care.

The recalled units were distributed nationwide in the United States, including Puerto Rico. Healthcare facilities and medical personnel who use this product should be aware of this recall.

Healthcare providers should immediately cease use of affected batch numbers and quarantine existing inventory. Patients currently using affected devices should consult with their healthcare provider immediately. For a complete list of affected batch numbers and further instructions, healthcare providers should contact Teleflex directly or visit the FDA website.

The recalled product

Product
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170080
Manufacturer
TELEFLEX LLC
Hazard
  • connector-disconnection
  • ventilation-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 (20)

  • UDI/DI 4026704319596
  • Batch Numbers: 18FG09
  • 18FG20
  • 18FT32
  • 18GG05
  • 18GG08
  • 18GG14
  • 18HG07
  • 18HG12
  • 18HG22
  • 18HG27
  • 18HG35
  • 18IG02
  • 18IG09
  • 18IG15
  • 18JG04
  • 18JG06
  • 18JG14
  • 18JG26
  • 18LG12

Distribution

Distributed nationwide across the United States.