The Recall Desk
CriticalFDA (Devices)·Z-2314-2019·Announced 2019-09-18

Teleflex Medical Recalls Sheridan Preformed Tracheal Tubes Due to Disconnection Risk

Teleflex Medical is recalling specific lots of Hudson RCI Sheridan Preformed tracheal tubes because the 15 mm connector may disconnect from the tube, potentially causing insufficient oxygenation.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The FDA has classified this recall as Class I, which is defined as a situation where there is a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death. The rubric mandates a score of 5 for any FDA Class I recall.

Plain-English summary

Teleflex Medical is recalling specific lots of Hudson RCI Sheridan Preformed tracheal tubes used for airway management. The recall involves 278,142 units distributed nationwide in the United States. The affected products include various sizes ranging from 3.0 mm to 9.0 mm, identified by specific reference numbers and batch numbers listed in the official recall notice.

The recall was initiated due to reported complaints indicating an increased incidence of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube. 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 consumers who have these specific products should stop using them and contact Teleflex Medical for instructions on how to return the devices. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.

The recalled product

Product
Hudson RCI Sheridan Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 mm, REF 5-22007, REF 5-22107 c) 4.0 mm, REF 5-22008, REF 5-22108, REF 5-22208 d) 4.5 mm, REF 5-22009, REF 5-22109, REF 5-22209 e) 5.0 mm, REF 5-22010, REF 5-22110, REF 5-22210 f) 5.5 mm, REF 5-22011,
Manufacturer
Teleflex Medical
Category
Medical Device — Airway Management
Hazard
Affected units
278,142

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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