Teleflex Slick Set endotracheal tubes recalled for connector disconnection
Teleflex Slick Set endotracheal tubes (REF 170055) are being recalled by the FDA following reports of disconnection of the 15mm connector. This Class I recall affects approximately 3,530 units distributed nationwide.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I classification by the FDA designates this as a Critical recall. The severity rubric specifies that FDA Class I device recalls receive Critical severity due to reasonable probability of serious adverse health consequences.
Plain-English summary
Teleflex is recalling the Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170055. The FDA classified this as a Class I recall.
The recall was initiated following reports of disconnection of the 15mm connector from the endotracheal tube.
Approximately 3,530 units were distributed nationwide throughout the United States, including Puerto Rico. The affected products are identified by UDI/DI 4026704319541 and bear specific batch numbers documented by the FDA.
The recalled product
- Product
- Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170055
- 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 4026704319541
- Batch numbers: 18FG18
- 18GG14
- 18GG31
- 18HG22
- 18KG23
- 19BG12
- 19ET72
- 19IT25
- 20AT25
- 20AT32
- 20BT05
- 20BT37
- 20BT47
- 20ET21
- KME20G0383
- KME20K0936
- KME20K2587
- KME20L1469
- KME20L2378
Distribution
Distributed nationwide across the United States.
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