Flexi-Set Cuffed Endotracheal Tube Recall: Connector Disconnection Risk
Teleflex is recalling Flexi-Set Cuffed Endotracheal Tubes due to reports of 15mm connector disconnection. The recall affects 66,310 units 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 Class I classification indicates a serious hazard with an airway management device. Although no illnesses or injuries have been reported, connector disconnection presents significant risk of patient harm. FDA Class I recalls are scored at minimum Severe (4) per rubric guidance.
Plain-English summary
Teleflex is recalling the Flexi-Set Cuffed Endotracheal Tube and Stylet Set (REF 504550) for oral and nasal intubation due to reports of 15mm connector disconnection from the endotracheal tube.
The recall affects 66,310 units distributed nationwide in the United States and Puerto Rico. Affected devices are identified by UDI/DI 4026704547579 and include 62 batch numbers produced between 2018 and 2022.
Healthcare facilities and providers should immediately stop using affected units and contact Teleflex for replacement, credit, or other instructions. Verify batch numbers against the recall list to determine if your units are affected.
The recalled product
- Product
- Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504550
- 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 4026704547579
- Batch Numbers: 18FG03
- 18FG13
- 18GG12
- 18GG17
- 18GG31
- 18HG12
- 18IG02
- 18IG12
- 18IG21
- 18IG27
- 18JG02
- 18KG15
- 18LG25
- 18LG37
- 19AG37
- 19BG07
- 19BG21
- 19CT71
- 19ET54
Distribution
Distributed nationwide across the United States.
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