Flexi-Set Uncuffed Endotracheal Tubes recalled for connector disconnection risk
TELEFLEX LLC recalls Flexi-Set Uncuffed Endotracheal Tube and Stylet Sets due to reports of the 15mm connector disconnecting from the tube. Approximately 16,400 units distributed nationwide are affected.
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 Class I medical device recall. The connector disconnection can compromise airway management functionality, creating serious risk of patient harm during use. No deaths or serious injuries have been reported in the source material.
Plain-English summary
TELEFLEX LLC is recalling the Flexi-Set Uncuffed Endotracheal Tube and Stylet Set (oral/nasal, REF 506540), a medical device used for airway management. Reports indicate that the 15mm connector is disconnecting from the endotracheal tube in affected units. This connector disconnection could compromise the functionality of the airway management system, creating a serious risk of harm during use.
The recall affects approximately 16,400 units distributed nationwide, including Puerto Rico. These units are identified by UDI/DI 4026704547692 and are associated with specific batch numbers documented in the official FDA recall notice.
Healthcare facilities and medical professionals that have received these units should review the recall information and consult the FDA documentation for guidance on affected batch numbers and recommended actions.
The recalled product
- Product
- Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506540
- Manufacturer
- TELEFLEX LLC
- Category
- Medical Device
- 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 4026704547692
- Batch Numbers: 18FG05
- 18FG13
- 18FG22
- 18GG17
- 18GG28
- 18GT32
- 18HG16
- 18JG02
- 18JG17
- 18JG32
- 18JG34
- 18KG29
- 18KG35
- 18LG02
- 18LG12
- 18LG18
- 18LG28
- 19AG21
- 19BG21
Distribution
Distributed nationwide across the United States.
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