Teleflex Flexi-Set Endotracheal Tubes Recalled for Connector Disconnection
Teleflex is recalling 32,553 units of Flexi-Set Uncuffed Endotracheal Tubes nationwide due to reports of 15mm connector disconnections that could compromise airway management.
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 classification requires a minimum severity score of 4. The source documents actual connector disconnections but does not report any patient injuries, illnesses, or deaths, placing this at Severe rather than Critical.
Plain-English summary
Teleflex LLC is recalling the Flexi-Set Uncuffed Endotracheal Tube and Stylet Set (REF 506530) due to reports of disconnection of the 15mm connector from the endotracheal tube. This disconnection could impair airway management during patient care.
The recalled product was distributed nationwide, including Puerto Rico. Approximately 32,553 units are affected, identified by UDI/DI 4026704547678 and specific batch numbers listed by the FDA.
Healthcare facilities and providers using this product should stop use and contact Teleflex with questions or to arrange replacement products. Patients or healthcare providers who believe they have experienced a connection failure should report the incident to Teleflex or contact the FDA.
The recalled product
- Product
- Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506530
- 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 4026704547678
- Batch Numbers: 18FG05
- 18GG12
- 18GG17
- 18GG31
- 18GT32
- 18HG12
- 18HG16
- 18IG02
- 18IG06
- 18IG15
- 18IG21
- 18IG27
- 18JG02
- 18JG23
- 18JG32
- 18JG34
- 18KG15
- 18KG23
- 18LG02
Distribution
Distributed nationwide across the United States.
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