The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1895-2023·Announced 2023-07-05

RUSCHELIT Safety Clear Tracheal Tubes recalled for connector disconnection risk

Teleflex is recalling RUSCHELIT Safety Clear Tracheal Tubes due to reports of 15mm connector disconnection. The affected tubes are distributed nationwide.

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 classified as FDA Class I, which requires a minimum severity of 4 per the rubric. The product is a critical airway management device, and connector disconnection represents a functional failure. No deaths or hospitalizations are explicitly reported in the source; therefore, the score is 4 (Severe) rather than 5.

Plain-English summary

TELEFLEX LLC is recalling RUSCHELIT Safety Clear Tracheal Tubes (oral/nasal, Magill, REF 112480025) nationwide due to reports of the 15mm connector disconnecting from the endotracheal tube. Approximately 66,244 units are affected, distributed across the United States and Puerto Rico.

The disconnection of the connector could affect proper airway management. The recall involves tracheal tubes with UDI/DI 14026704341495 and specific batch numbers spanning from 2018 to 2022.

Healthcare facilities using these tubes should verify their inventory against the affected batch list and discontinue use of recalled units. Contact TELEFLEX LLC for replacement or return instructions.

The recalled product

Product
RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480025
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway / Tracheal Tube
Hazard
Affected units
66,244

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 14026704341495
  • Batch Numbers: 18FG31
  • 18GT32
  • 18IG03
  • 18IG29
  • 18KG08
  • 18LG03
  • 19AG08
  • 19AG38
  • 19BG12
  • 19BG35
  • 19DT13
  • 19DT36
  • 19ET51
  • 19FT12
  • 19FT28
  • 19GT02
  • 19HT05
  • 19HT79
  • 19IT59

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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