The Recall Desk
Agency classClass IOur severity: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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Category
Medical Device — Respiratory
Hazard
Affected units
1,460

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.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 123 recalled by TELEFLEX LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 123 products in this recall →

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