Agency classClass IOur severity:Severe FDA (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.

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: "Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation…"

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…
Manufacturer: Teleflex Medical
Category: Medical Device — Airway Management
Hazard: disconnection
insufficient-oxygenation
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 →

Same manufacturer · Teleflex Medical

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Same hazard · disconnection