Agency classClass IOur severity:Severe FDA (Devices)·Z-2313-2019·Announced 2019-09-18

Teleflex Recalls Sheridan EZ-ENDO Tracheal Tubes Due to Disconnection Risk

Teleflex Medical is recalling specific lots of Sheridan EZ-ENDO tracheal tubes because the 15 mm connector may disconnect, 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 specific lots of the Hudson RCI Sheridan EZ-ENDO tracheal tube. The recall covers nine different sizes of the device, ranging from 5.0 mm to 9.0 mm, with a total of 57,181 units distributed nationwide in the United States.

The recall was initiated due to reported complaints indicating an increased incidence of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube. This disconnection from the breathing circuit may result in insufficient oxygenation for the patient, which could require medical intervention.

Healthcare facilities and users of these devices should check their inventory for the specific reference numbers and batch numbers listed in the recall notice. If the affected units are found, they should be removed from service and returned to Teleflex Medical for further instructions.

The recalled product

Product: Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 c) 7.0 mm, REF 5-22514 d) 7.5 mm, REF 5-22515 e) 8.0 mm, REF 5-22516 f) 8.5 mm, REF 5-22517 g) 9.0 mm, REF 5-22518 h) 6.0 mm, REF 5-22512 i) 6.5 mm, REF 5-22513 Product Usage: Tracheal…
Manufacturer: Teleflex Medical
Category: Medical Device — Airway Management
Hazard: disconnection
insufficient-oxygenation
Affected units: 57,181

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