Teleflex Recalls Sheridan EZ-ENDO Tracheal Tubes Due to Disconnection Risk
Teleflex Medical is recalling specific lots of Sheridan EZ-ENDO tracheal tubes because the 15 mm connector may disconnect, potentially causing insufficient oxygenation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where disconnection may result in insufficient oxygenation requiring medical intervention. This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Teleflex Medical is recalling specific lots of the Hudson RCI Sheridan EZ-ENDO tracheal tube. The recall covers nine different sizes of the device, ranging from 5.0 mm to 9.0 mm, with a total of 57,181 units distributed nationwide in the United States.
The recall was initiated due to reported complaints indicating an increased incidence of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube. This disconnection from the breathing circuit may result in insufficient oxygenation for the patient, which could require medical intervention.
Healthcare facilities and users of these devices should check their inventory for the specific reference numbers and batch numbers listed in the recall notice. If the affected units are found, they should be removed from service and returned to Teleflex Medical for further instructions.
The recalled product
- Product
- Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 c) 7.0 mm, REF 5-22514 d) 7.5 mm, REF 5-22515 e) 8.0 mm, REF 5-22516 f) 8.5 mm, REF 5-22517 g) 9.0 mm, REF 5-22518 h) 6.0 mm, REF 5-22512 i) 6.5 mm, REF 5-22513 Product Usage: Tracheal tube/
- Manufacturer
- Teleflex Medical
- Affected units
- 57,181
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Teleflex Medical 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.
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