Teleflex Recalls Sheridan/CF Novaplus Tracheal Tubes Due to Connector Disconnection
Teleflex Medical is recalling Sheridan/CF Novaplus 7.0 mm tracheal tubes because the Sheridan connector may disconnect from the tube, 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 a defect (connector disconnection) poses a risk of harm (insufficient oxygenation requiring medical intervention), but no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Teleflex Medical is recalling Sheridan/CF Novaplus 7.0 mm tracheal tubes (REF V5-10114) used for airway management. The recall involves 77,136 units distributed nationwide in the United States. Specific batch numbers are listed in the agency's recall record.
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, which could require medical intervention.
Healthcare facilities and consumers should check their inventory for the affected product reference number and batch numbers. If the product is found, it should be removed from use and returned to Teleflex Medical or the distributor in accordance with the recall instructions.
The recalled product
- Product
- Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management
- Manufacturer
- Teleflex Medical
- Affected units
- 77,136
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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