The Recall Desk
ModerateFDA (Devices)·Z-1765-2019·Announced 2019-06-26

Teleflex Recalls Sheridan/CF Novaplus Tracheal Tubes Due to Connector Issues

Teleflex Medical is voluntarily recalling specific lots of Sheridan/CF Novaplus 7.0 mm tracheal tubes because the 15 mm Sheridan connector may disconnect from the tube.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class I, which typically indicates a low probability of adverse health consequences. The hazard is a mechanical disconnection, and the source text does not report any injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Teleflex Medical is voluntarily recalling 77,136 units of Sheridan/CF Novaplus 7.0 mm tracheal tubes (Product Code V5-10114). These devices are used for tracheal tube and airway management. The recall covers specific lots distributed worldwide and nationwide in the US.

The recall was initiated due to reported complaints indicating an increased incidence of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube. The source text notes that these complaints represent less than 0.0025% of all in-scope distributed product.

Healthcare facilities and distributors should stop using the affected lots and contact Teleflex Medical for instructions on return or replacement. Patients should consult their healthcare providers if they have questions regarding the use of these devices.

The recalled product

Product
Sheridan/CF Novaplus 7.0 mm, Product Code 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.

See all 8 products in this recall →