Agency classClass IOur severity:Severe FDA (Devices)·Z-2315-2019·Announced 2019-09-18

Teleflex Recalls Hudson RCI Sheridan Uncuffed Tracheal Tubes

Teleflex Medical is recalling Hudson RCI Sheridan Uncuffed tracheal tubes because specific lots of the 15 mm connector may disconnect from the 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 170,740 units of Hudson RCI Sheridan Uncuffed tracheal tubes, which are used for tracheal tube and airway management. The recall covers 11 specific sizes ranging from 2.0 mm to 7.0 mm, identified by reference numbers 5-10404 through 5-10414. The affected products were distributed nationwide in the United States.

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. This disconnection from the breathing circuit may result in insufficient oxygenation, which could require medical intervention.

Healthcare facilities and users should check their inventory for the specific reference numbers and batch numbers listed in the official recall notice. If the product is found, it should be removed from service and returned to Teleflex Medical or the distributor in accordance with the recall instructions.

The recalled product

Product: Hudson RCI Sheridan Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-10405 c) 3.0 mm, REF 5-10406 d) 3.5 mm, REF 5-10407 e) 4.0 mm, REF 5-10408 f) 4.5 mm, REF 5-10409 g) 5.0 mm, REF 5-10410 h) 5.5 mm, REF 5-10411 i) 6.0 mm, REF 5-10412 j) 6.5 mm, REF 5-10413 k) 7.0…
Manufacturer: Teleflex Medical
Category: Medical Device — Airway Management
Hazard: disconnection
insufficient-oxygenation
Affected units: 170,740

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

See all →

Low
Teleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
Low
Teleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
Moderate
Teleflex Sheridan Endobronchial Tubes Recalled for Incorrect Labeling
FDA (Devices) · 2019-12-25
High
Teleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25
High
Teleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25

Same hazard · disconnection