The Recall Desk
SevereFDA (Devices)·Z-1835-2023·Announced 2023-07-05

Slick Set Cuffed Endotracheal Tube Connector Disconnection Recall

Teleflex is recalling Slick Set Cuffed Endotracheal Tubes because the 15mm connector may disconnect from the tube. The recall affects 1,460 units distributed nationwide, including Puerto Rico.

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 medical device recall. FDA Class I medical device classifications establish a minimum severity score of 4 (Severe) due to the inherent potential for serious adverse health consequences associated with device malfunctions.

Plain-English summary

Teleflex LLC is recalling the Slick Set Cuffed Endotracheal Tube and Stylet Set (oral/nasal, REF 170090) due to reports of disconnection of the 15mm connector from the endotracheal tube.

The recalled product was distributed nationwide, including Puerto Rico, with 1,460 units involved. Affected batch numbers are: 18FG09, 18HG27, 18IG12, 18LG18, 19GT52, 19GT65, 19HT35, 20AT25, KME20L0625, KME21E1232, KME22E2491, and KME22E2912. The product identifier is UDI/DI 4026704319619.

The recalled product

Product
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170090
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 (13)

  • UDI/DI 4026704319619
  • Batch Numbers: 18FG09
  • 18HG27
  • 18IG12
  • 18LG18
  • 19GT52
  • 19GT65
  • 19HT35
  • 20AT25
  • KME20L0625
  • KME21E1232
  • KME22E2491
  • KME22E2912

Distribution

Distributed nationwide across the United States.