TELEFLEX Endotracheal Tubes Recalled for 15mm Connector Disconnection
TELEFLEX is recalling 5,990 endotracheal tubes due to reports of 15mm connector disconnection. Affected units were distributed nationwide, including Puerto Rico.
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. Class I indicates a reasonable probability that the defect will cause serious injury or death. No illnesses or injuries have been reported; however, the Class I designation establishes a minimum severity score of 4 per the rubric.
Plain-English summary
TELEFLEX LLC is recalling 5,990 Magill endotracheal tubes (ET tubes) due to reports of the 15mm connector disconnecting from the device. The endotracheal tube is a respiratory device used to maintain an open airway during anesthesia or mechanical ventilation. If the connector disconnects during use, it could compromise the patient's airway.
The affected product is Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380030 (UDI/DI 14026704340627). Affected batch numbers are 19ET31, 19FT28, 19GT08, 19GT31, 19GT35, 19GT48, 19HT05, 19HT32, 19HT60, 19IT38, 20DT09, 20DT24, 20ET03, 20FT55, and 20GT37. The recall affects units distributed nationwide, including Puerto Rico.
If you have this product, do not use it and contact TELEFLEX LLC.
The recalled product
- Product
- Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380030
- 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 (16)
- UDI/DI 14026704340627
- Batch Numbers: 19ET31
- 19FT28
- 19GT08
- 19GT31
- 19GT35
- 19GT48
- 19HT05
- 19HT32
- 19HT60
- 19IT38
- 20DT09
- 20DT24
- 20ET03
- 20FT55
- 20GT37
Distribution
Distributed nationwide across the United States.
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