The Recall Desk
ModerateFDA (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.

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, and the source text describes it as a voluntary recall with a very low complaint rate (<0.0025%) and no reported injuries or illnesses.

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 tube/airw
Manufacturer
Teleflex Medical
Category
Medical Device — Airway Management
Hazard
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 →

Related recalls

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Same hazard · device disconnection

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