Flexi-Set Uncuffed Endotracheal Tube Sets recalled for connector disconnection
Teleflex is recalling approximately 10,600 Flexi-Set Uncuffed Endotracheal Tube and Stylet Sets due to reports that the 15mm connector may disconnect from the tube during use.
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. Per classification rules, FDA Class I recalls score no lower than 4. The hazard—connector disconnection from a critical airway device—poses significant risk during patient ventilation.
Plain-English summary
Teleflex LLC is recalling approximately 10,600 Flexi-Set Uncuffed Endotracheal Tube and Stylet Sets (REF 506550) distributed nationwide in the United States and Puerto Rico. These medical devices are used for airway management during intubation procedures in healthcare settings.
Reports indicate that the 15mm connector may disconnect from the endotracheal tube. This disconnection could compromise the secure connection between the tube and ventilation equipment during patient care.
Healthcare facilities that received these products should identify and discontinue use of affected units. Contact Teleflex LLC for information regarding device replacement, return, or proper disposal.
The recalled product
- Product
- Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506550
- 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 4026704547715
- Batch Numbers: 18FG01
- 18FG05
- 18FG13
- 18GG17
- 18GG31
- 18HG12
- 18HG19
- 18JG21
- 18JG32
- 18KG41
- 18LG18
- 18LG28
- 19AG21
- 19DT25
- 19DT33
- 19ET54
- 19ET77
- 19FT24
- 19GT59
Distribution
Distributed nationwide across the United States.
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