The Recall Desk
HighFDA (Devices)·Z-2312-2019·Announced 2019-09-18

Teleflex Medical Recalls Hudson RCI Sheridan/CF Tracheal Tubes

Teleflex Medical is recalling Hudson RCI Sheridan/CF tracheal tubes because specific lots of the 15 mm Sheridan connector may disconnect from the endotracheal 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 disconnection can lead to insufficient oxygenation requiring medical intervention. This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported, as the source text describes potential consequences rather than confirmed injuries or deaths.

Plain-English summary

Teleflex Medical is recalling Hudson RCI Sheridan/CF tracheal tubes, which are used for airway management. The recall affects 1,805,730 units distributed nationwide in the United States. The affected products include various sizes ranging from 3.0 mm to 10.0 mm, identified by specific reference numbers and batch numbers listed in the recall documentation.

The recall was initiated due to reported complaints indicating an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). If the connector disconnects from the breathing circuit, it may result in insufficient oxygenation for the patient, which would require medical intervention.

Healthcare facilities and providers should check their inventory for the affected reference numbers and batch numbers. If any of these units are found, they should be removed from service and returned to Teleflex Medical according to the company's instructions.

The recalled product

Product
Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c) 4.0 mm, REF 5-10108, REF 5-10208 d) 4.5 mm, REF 5-10109 e) 5.0 mm, REF 5-10110, REF 5-10210 f) 5.5 mm, REF 5-10111 g) 6.0 mm, REF 5-10112, REF 5-10212 h) 6.5 mm, REF 5-10113, REF 5-1021
Manufacturer
Teleflex Medical
Category
Medical Device — Airway Management
Hazard
Affected units
1,805,730

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 →

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