Endotracheal Tube Connector Disconnection Risk in Flexi-Set Kit
Flexi-Set Cuffed Endotracheal Tube kits are being recalled due to reports of the 15mm connector disconnecting from the tube. Affected units were distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA classified this as a Class I recall, which mandates a minimum severity of Severe per the rubric. While no deaths or injuries are reported in the source text, connector disconnection in critical airway management equipment represents a serious potential safety hazard.
Plain-English summary
Teleflex LLC is recalling Flexi-Set Cuffed Endotracheal Tube and Stylet Sets (REF 504555) due to reports of disconnection of the 15mm connector from the endotracheal tube.
The affected products include 42,214 units distributed nationwide in the United States and Puerto Rico. Multiple batch numbers are affected, spanning production from 2018 to 2023.
Healthcare facilities using these products should immediately cease use of affected units and consult the FDA recall notice for batch identification and proper procedures. Affected products are identified by UDI/DI number 4026704547586.
The recalled product
- Product
- Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504555
- Manufacturer
- TELEFLEX LLC
- Hazard
- connector-disconnection
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 4026704547586
- Batch Numbers: 18FG20
- 18FG22
- 18FG25
- 18FT32
- 18GG14
- 18HG12
- 18HG27
- 18IG06
- 18IG24
- 18IG27
- 18JG02
- 18JG14
- 18KG07
- 18KG23
- 18KG35
- 18LG31
- 19AG27
- 19BG04
- 19CT55
Distribution
Distributed nationwide across the United States.
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