Agency classClass IOur severity:Severe FDA (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.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal…"

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
Category: Medical Device — Airway Management
Hazard: mechanical-failure
disconnection
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 →

Same manufacturer · Teleflex Medical

See all →

Low
Teleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
Low
Teleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
Moderate
Teleflex Sheridan Endobronchial Tubes Recalled for Incorrect Labeling
FDA (Devices) · 2019-12-25
High
Teleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25
High
Teleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25

Same hazard · mechanical failure