The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1860-2023·Announced 2023-07-05

Endotracheal Tube Connector Disconnection Recall

TELEFLEX LLC is recalling Slick Set Cuffed Endotracheal Tubes (REF 1700100) due to reports of the 15mm connector disconnecting from the device during use.

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: FDA Class I medical device recall. Per the severity rubric, FDA Class I recalls must be scored at minimum 4 (Severe). The endotracheal tube is a critical airway management device; connector disconnection could impair ventilation and oxygen delivery.

Plain-English summary

TELEFLEX LLC is recalling the Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal (REF 1700100), distributed nationwide including Puerto Rico. The recall affects approximately 190 units with batch numbers 18IG06 and 18KG44 (UDI/DI 4026704319633).

Reports have been received of the 15mm connector disconnecting from the endotracheal tube. Disconnection of the connector could impair airway management during procedures in which the device is in use.

Healthcare facilities and providers should identify affected products by batch number. Contact TELEFLEX LLC or consult FDA recall guidance for instructions regarding product removal, replacement, or proper disposition.

The recalled product

Product
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 1700100
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management
Hazard
Affected units
190

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 (3)

  • UDI/DI 4026704319633
  • Batch Numbers: 18IG06
  • 18KG44

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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