The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1897-2023·Announced 2023-07-05

RUSCHELIT Safety Clear Tracheal Tube 15mm connector disconnection risk nationwide recall

Teleflex is recalling 31,945 RUSCHELIT Safety Clear Tracheal Tubes nationwide due to reports of 15mm connector disconnection from the endotracheal tube.

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 designation requires a minimum severity of Severe. No deaths, serious injuries, or hospitalizations are documented in the source text; however, the reported connector disconnections on this airway management device justify this classification level.

Plain-English summary

Teleflex LLC is recalling 31,945 units of the RUSCHELIT Safety Clear Tracheal Tube (REF 112480035), an oral/nasal endotracheal tube, due to reports of the 15mm connector disconnecting from the tube.

The affected products were distributed nationwide in the United States, including Puerto Rico, under multiple batch numbers and UDI-DI 14026704341518.

Healthcare facilities should stop using affected units immediately and contact Teleflex LLC or their medical device supplier for product return instructions and replacement options.

The recalled product

Product
RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480035
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management / Tracheal Tube
Hazard
Affected units
31,945

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 14026704341518
  • Batch Numbers: 18GG15
  • 18GG16
  • 18IG01
  • 18IG03
  • 18IG04
  • 18IG13
  • 18LG30
  • 19BG16
  • 19BG35
  • 19DT35
  • 19ET51
  • 19GT51
  • 19IT38
  • 19JT20
  • 19JT50
  • 19KT37
  • 19KT60
  • 19LT03
  • 19LT27

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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