The Recall Desk
HighFDA (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.

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 may result in insufficient oxygenation requiring medical intervention, fitting the criterion for risk-of-harm products where injury has not yet been reported.

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
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 →