The Recall Desk
HighFDA (Devices)·Z-1010-2023·Announced 2023-02-01

Endotracheal Tubes May Fail to Inflate Pilot Balloon or Deflate Cuff

TELEFLEX LLC is recalling 2,270 units of Slick Set Endotracheal Tubes due to potential pilot balloon non-inflation or cuff non-deflation. The devices were distributed worldwide including the United States.

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 an FDA Class II recall of a medical device with potential malfunctions in critical safety features (pilot balloon and cuff). No illnesses or injuries have been reported, placing this in the High category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

TELEFLEX LLC is recalling 2,270 units of Slick Set Cuffed Endotracheal Tube and Stylet Sets, intended for patients requiring endotracheal intubation. The affected product codes are 170060, 170070, 170075, 170080, 170085, and 170090, with specific lot numbers and UDI information provided by the manufacturer.

The recall is due to a potential malfunction where the pilot balloon may fail to inflate or the cuff may fail to deflate. These are critical safety features that ensure proper tube placement and cuff function during endotracheal intubation.

The recalled units were distributed worldwide, including throughout the United States.

Patients and healthcare providers should not use the affected batches. Contact TELEFLEX LLC or the FDA for specific product code information, detailed lot numbers, and replacement options.

The recalled product

Product
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended for patients requiring endotracheal intubation
Manufacturer
TELEFLEX LLC
Category
Medical Device — Endotracheal Tube / Airway Management
Hazard
  • pilot-balloon-non-inflation
  • cuff-non-deflation

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 (18)

  • a. Product Code: 170060
  • Batch Number: KME21E1411
  • UDI: (01)04026704319558(17)260428(10)KME21E1411
  • b. Product Code: 170070
  • Batch Number (UDI): KME21D1430 ((01)04026704319572(17)260328(10)KME21D1430)
  • KME21E1290 ((01)04026704319572(17)260428(10)KME21E1290)
  • c. Product Code: 170075
  • Batch Number: KME21D1785
  • UDI:(01)04026704319589(17)260328(10)KME21D1785
  • d. Product Code: 170080
  • Batch Number (UDI): KME21D1204 ((01)04026704319596(17)260328(10)KME21D1204)
  • KME21E1287 ((01)04026704319596(17)260428(10)KME21E1287)
  • e. Product Code: 170085
  • Batch Number: KME21E1296
  • UDI:(01)4026704319602(17)260428(10)KME21E1296
  • f. Product Code: 170090
  • Batch Number: KME21E1232
  • UDI: (01)4026704319619(17)260428(10)KME21E1232

Distribution

Distributed nationwide across the United States.

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