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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- Affected units
- 3,530
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
Part of a larger recall action
This product is one of 123 recalled by TELEFLEX LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 123 products in this recall →Related recalls
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