The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1896-2023·Announced 2023-07-05

Tracheal tube connector disconnection reported in RUSCHELIT Safety Clear models

TELEFLEX LLC is recalling RUSCHELIT Safety Clear Tracheal Tubes due to reports of 15mm connector disconnection. The recall involves 21,284 units 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: The FDA has classified this as a Class I recall, the most serious medical device classification. While no illnesses or injuries are reported in the source text, the critical function of the tracheal tube in airway management justifies this classification.

Plain-English summary

TELEFLEX LLC is recalling the RUSCHELIT Safety Clear Tracheal Tube, oral/nasal Magill design (REF 112480030). This endotracheal tube is used for airway management in medical settings. Affected units are identified by UDI/DI 14026704341501 and include multiple batch numbers listed in the recall notice.

The recall was initiated due to reports of disconnection of the 15mm connector from the endotracheal tube, which is critical for maintaining proper airway support.

Approximately 21,284 units were distributed nationwide, including Puerto Rico. Healthcare facilities and medical professionals who received these tubes should check their inventory against the list of affected batch numbers.

Users should immediately discontinue use of affected batches and contact TELEFLEX LLC for replacement units or return instructions. Any adverse events related to this product should be reported to the FDA.

The recalled product

Product
RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480030
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management
Hazard
Affected units
21,284

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 14026704341501
  • Batch Numbers: 18GG16
  • 18HG10
  • 18HG25
  • 18IG03
  • 19BG12
  • 19BG16
  • 19CT42
  • 19CT64
  • 19DT36
  • 19ET09
  • 19ET31
  • 19ET53
  • 19GT02
  • 19IT38
  • 19JT21
  • 19JT55
  • 19KT20
  • 19KT37
  • 19LT31

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

See all →

Similar recalls