Flexi-Set Endotracheal Tubes recalled for connector disconnection
Teleflex is recalling over 1 million Flexi-Set Cuffed Endotracheal Tube kits due to reports of 15mm connector disconnection from the tube. The recall affects products 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: The FDA classified this as a Class I recall, which requires a minimum severity score of 4. Disconnection of the 15mm connector on an endotracheal tube affects a critical medical device with direct patient contact during airway procedures.
Plain-English summary
Teleflex LLC is recalling the Flexi-Set Cuffed Endotracheal Tube and Stylet Set (REF 504570) due to reports of disconnection of the 15mm connector from the endotracheal tube. The endotracheal tube is a medical device used for oral and nasal intubation in clinical settings.
The recall affects approximately 1,051,810 units distributed nationwide, including Puerto Rico. The affected batch numbers span from 2018 through 2022 and are identified by UDI/DI 4026704547616 along with additional KME batch codes.
Healthcare facilities and patients should verify whether their supplies match any of the recalled batch numbers and contact the manufacturer for guidance on replacement or corrective action.
The recalled product
- Product
- Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504570
- Manufacturer
- TELEFLEX LLC
- Hazard
- connector-disconnection
- medical-device-defect
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 4026704547616
- Batch Numbers: 18FG03
- 18FG13
- 18FG21
- 18FG22
- 18FG30
- 18FT32
- 18GG02
- 18GG08
- 18GG20
- 18GT32
- 18HG07
- 18HG16
- 18HG19
- 18HG32
- 18HG35
- 18HG38
- 18IG02
- 18IG06
- 18IG12
Distribution
Distributed nationwide across the United States.
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