The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1852-2023·Announced 2023-07-05

Flexi-Set Endotracheal Tubes Recalled Due to Connector Disconnection Risk

TELEFLEX LLC is recalling Flexi-Set Cuffed Endotracheal Tube and Stylet Sets nationwide due to reports of the 15mm connector disconnecting from the tube, posing a serious risk in critical care settings.

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 an FDA Class I medical device recall. Per the severity rubric, FDA Class I classifications cannot score below 4, as they indicate a serious health risk requiring immediate attention.

Plain-English summary

TELEFLEX LLC is recalling the Flexi-Set Cuffed Endotracheal Tube and Stylet Set (REF 504585) nationwide, including Puerto Rico. The recall was issued because the 15mm connector can disconnect from the endotracheal tube. This disconnection poses a serious risk for patients who depend on these tubes for airway management during medical procedures and critical care.

Approximately 56,640 units were distributed. The affected products can be identified by UDI/DI 4026704547647. Multiple batch numbers are affected, spanning from 2018 through 2022.

Healthcare providers who have this product should verify their stock against the list of affected batch numbers available in the FDA recall notice. Facilities should follow TELEFLEX LLC's guidance for product replacement and handling of existing inventory to prevent use of affected units.

The recalled product

Product
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504585
Manufacturer
TELEFLEX LLC
Category
Medical Device — Endotracheal Tubes
Hazard
Affected units
56,640

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 4026704547647
  • Batch Numbers: 18FG13
  • 18FG15
  • 18FG25
  • 18GG20
  • 18GG28
  • 18HG12
  • 18HG19
  • 18IG06
  • 18IG27
  • 18JG02
  • 18JG23
  • 18JG26
  • 18KG18
  • 18KG23
  • 19AG05
  • 19AG31
  • 19AG37
  • 19CT17
  • 19CT58

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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