The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1836-2023·Announced 2023-07-05

Teleflex Slick Set Endotracheal Tube Connector May Disconnect

Teleflex recalled 720 units of its Slick Set Cuffed Endotracheal Tube and Stylet Set due to reports of connector disconnection. The recall affects 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 device recall. Per the severity rubric, FDA Class I classifications require a minimum severity score of 4. No deaths or reported injuries are documented in the source text.

Plain-English summary

Teleflex LLC has recalled 720 units of its Slick Set Cuffed Endotracheal Tube and Stylet Set (REF 170095) distributed nationwide including Puerto Rico. The recall was initiated due to reports of the 15mm connector disconnecting from the endotracheal tube.

The affected product is used in medical settings for airway management via oral or nasal routes. Affected batch numbers are 19HT48, 19KT17, 20AT53, 20BT37, KME22E2493, KME22F1387, and KME22H0342, with UDI/DI 4026704319626.

The recalled product

Product
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170095
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management
Hazard
Affected units
720

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 (8)

  • UDI/DI 4026704319626
  • Batch Numbers: 19HT48
  • 19KT17
  • 20AT53
  • 20BT37
  • KME22E2493
  • KME22F1387
  • KME22H0342

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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