The Recall Desk
HighFDA (Devices)·Z-2316-2019·Announced 2019-09-18

Teleflex Medical Recalls Hudson RCI Sheridan/HVT Tracheal Tubes

Teleflex Medical is recalling specific lots of Hudson RCI Sheridan/HVT tracheal tubes because the 15 mm Sheridan 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 rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Teleflex Medical is recalling specific lots of Hudson RCI Sheridan/HVT tracheal tubes used for airway management. The recall involves 3,375,808 units distributed nationwide in the United States. The affected products are available in sizes ranging from 5.0 mm to 10.0 mm, with 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. This disconnection from the breathing circuit may result in insufficient oxygenation for the patient, which would require medical intervention.

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

The recalled product

Product
Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF 5-10312 d) 6.5 mm, REF 5-10313 e) 7.0 mm, REF 5-10314 f) 7.5 mm, REF 5-10315 g) 8.0 mm, REF 5-10316 h) 8.5 mm, REF 5-10317 i) 9.0 mm, REF 5-10318 j) 10.0 mm, REF 5-10320 Product Usa
Manufacturer
Teleflex Medical
Affected units
3,375,808

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 →