The Recall Desk
SevereFDA (Devices)·Z-1827-2023·Announced 2023-07-05

Endotracheal Tube and Stylet Set Connector May Disconnect During Use

TELEFLEX is recalling Slick Set Cuffed Endotracheal Tube and Stylet Sets due to reports that the 15mm connector may disconnect from the tube during use.

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: FDA classified this as a Class I recall. Regulatory guidance specifies that Class I recalls warrant a minimum severity score of 4. The connector disconnection represents a structural failure of a critical airway management device. No deaths or hospitalizations are reported in the source text.

Plain-English summary

TELEFLEX LLC is recalling the Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal (REF 170050), a medical device used for airway management in healthcare settings.

The 15mm connector on the endotracheal tube may disconnect from the tube. TELEFLEX received reports of this defect occurring.

Approximately 11,560 units were distributed nationwide, including Puerto Rico. Affected units can be identified by batch numbers 18FG05, 18GG08, 18GT32, 18HG38, 18JG02, 18JG11, 18KG15, 18LG22, 19AG24, 19DT06, 19DT33, 19ET28, 19FT18, 19IT25, 19KT48, 20AT14, 20DT09, 20ET04, 20GT31, KME20J1235, KME20J1238, KME20K2551, KME20L1089, KME20L2371, KME21A2064, KME21B2498, KME21F1552, KME21G1708, KME21K1248, KME21M2648, KME22B1391, KME22D1768, or KME22D1769, or UDI/DI 4026704319534. Healthcare facilities in possession of these units should discontinue use and contact TELEFLEX for replacement or return instructions.

The recalled product

Product
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170050
Manufacturer
TELEFLEX LLC
Category
Medical Device — Respiratory / Airway
Hazard
Affected units
11,560

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: 4026704319534
  • Batch numbers: 18FG05
  • 18GG08
  • 18GT32
  • 18HG38
  • 18JG02
  • 18JG11
  • 18KG15
  • 18LG22
  • 19AG24
  • 19DT06
  • 19DT33
  • 19ET28
  • 19FT18
  • 19IT25
  • 19KT48
  • 20AT14
  • 20DT09
  • 20ET04
  • 20GT31

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

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Same hazard · connector disconnection

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