The Recall Desk
HighFDA (Devices)·Z-1011-2023·Announced 2023-02-01

Endotracheal tubes recalled for potential pilot balloon and cuff malfunction

TELEFLEX LLC recalls 39,690 endotracheal tubes for potential pilot balloon non-inflation or cuff non-deflation. These critical airway devices may not function properly during patient intubation.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA recall for a critical airway management device with a functional failure risk. No illnesses or injuries are reported in the source material. Per the severity rubric, a risk-of-harm product where injury has not yet been reported scores as High (3).

Plain-English summary

TELEFLEX LLC is recalling endotracheal tubes marketed under several brand names including Flexi-Set Cuffed Endotracheal Tube and Stylet Set, Endotracheal Tube with Murphy Eye High Volume Low Pressure Cuff, and RUSCHELIT Super Safety Clear Tracheal Tube. Approximately 39,690 units are affected. These devices are intended for patients requiring endotracheal intubation for airway management.

The recall addresses a potential for pilot balloon non-inflation or cuff non-deflation. The pilot balloon regulates the inflatable cuff that creates a seal between the tube and the patient's airway. If the pilot balloon fails to inflate or the cuff fails to deflate properly, the tube may not function as intended.

The recalled products were distributed worldwide, including throughout the United States and internationally. Specific affected batch numbers are identified in the FDA recall notice.

Healthcare providers should verify whether they have received products matching the identified batch numbers. Affected units should be isolated from inventory pending review of recall guidance. Practitioners should contact TELEFLEX LLC or the FDA for instructions on specific batch numbers and recommended actions.

The recalled product

Product
Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. RUSCHELIT Super Safety Clear Tracheal Tube, oral/nasal, Murphy. Intended fo
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway / Respiratory
Hazard
  • pilot-balloon-failure
  • cuff-deflation-failure

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)

  • a. Product Code
  • Batch Number (UDI): 504550
  • KME21D1964 ((01)4026704547579(17)260328(10)KME21D1964)
  • 504560
  • KME21E1412 ((01)4026704547593(17)260428(10)KME21E1412)
  • 504580
  • KME21D1784 ((01)4026704547630(17)260328(10)KME21D1784)
  • KME21E1286 ((01)4026704547630(17)260428(10)KME21E1286)
  • 504585
  • KME21E1295 ((01)4026704547647(17)260428(10)KME21E1295)
  • 504590
  • KME21E1114 ((01)4026704547654(17)260428(10)KME21E1114)
  • b. Product Code
  • Batch Number (UDI): 112082050
  • KME21F0727 ((01)14026704341389(17)260528(10)KME21F0727)
  • 112082050
  • KME21F0321 ((01)14026704341389(17)260528(10)KME21F0321)
  • 112082055
  • KME21E0864 ((01)14026704341396(17)260428(10)KME21E0864)
  • KME21F0946 ((01)14026704341396(17)260528(10)KME21F0946)

Distribution

Distributed nationwide across the United States.

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