Agency classClass IOur severity:Severe FDA (Devices)·Z-1764-2019·Announced 2019-06-26

Teleflex Recalls Sheridan Tracheal Tubes Due to Connector Disconnection

Teleflex Medical is voluntarily recalling specific lots of Hudson RCI Sheridan tracheal tubes because the 15 mm 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 specific lots of Hudson RCI Sheridan tracheal tubes (sizes 6.0 mm to 8.5 mm) used for airway management. The recall involves approximately 3,238,600 units that were distributed nationwide in the United States and worldwide.

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

Healthcare facilities and consumers should check their inventory for the specific product codes and lot numbers listed in the official FDA recall notice Z-1764-2019. If the product is found, it should be removed from use and returned to Teleflex Medical for credit or replacement.

The recalled product

Product: Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Product Code 5-10313 3) HVT 7.0 mm, Product Code 5-10314 4) HVT 7.5 mm, Product Code 5-10315 5) HVT 8.0 mm, Product Code 5-10316 6) HVT 8.5 mm, Product Code 5-10317 Product Usage: Tracheal…
Manufacturer: Teleflex Medical
Category: Medical Device — Airway Management
Hazard: device-disconnection
Affected units: 3,238,600

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 (1)

1) HVT 6.0 mm

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

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Same hazard · device disconnection