The Recall Desk
CriticalFDA (Devices)·Z-1828-2023·Announced 2023-07-05

Teleflex Slick Set endotracheal tubes recalled for connector disconnection

Teleflex Slick Set endotracheal tubes (REF 170055) are being recalled by the FDA following reports of disconnection of the 15mm connector. This Class I recall affects approximately 3,530 units distributed nationwide.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: FDA Class I classification by the FDA designates this as a Critical recall. The severity rubric specifies that FDA Class I device recalls receive Critical severity due to reasonable probability of serious adverse health consequences.

Plain-English summary

Teleflex is recalling the Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170055. The FDA classified this as a Class I recall.

The recall was initiated following reports of disconnection of the 15mm connector from the endotracheal tube.

Approximately 3,530 units were distributed nationwide throughout the United States, including Puerto Rico. The affected products are identified by UDI/DI 4026704319541 and bear specific batch numbers documented by the FDA.

The recalled product

Product
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170055
Manufacturer
TELEFLEX LLC
Category
Medical Device
Hazard
Affected units
3,530

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 4026704319541
  • Batch numbers: 18FG18
  • 18GG14
  • 18GG31
  • 18HG22
  • 18KG23
  • 19BG12
  • 19ET72
  • 19IT25
  • 20AT25
  • 20AT32
  • 20BT05
  • 20BT37
  • 20BT47
  • 20ET21
  • KME20G0383
  • KME20K0936
  • KME20K2587
  • KME20L1469
  • KME20L2378

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 →

Related recalls

Same manufacturer · TELEFLEX LLC

See all →

Same hazard · connector disconnection

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