Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF 5-11112 Product Usage: Tracheal tube/airway management
Reported: September 18, 2019 Initiated: July 30, 2019 #Z-2311-2019
Product Description
Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF 5-11112 Product Usage: Tracheal tube/airway management
Reason for Recall
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, requiring medical intervention.
Details
- Recalling Firm
- Teleflex Medical
- Units Affected
- 7963 units
- Distribution
- US Nationwide Distribution
- Location
- Morrisville, NC
Frequently Asked Questions
What product was recalled? ▼
Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF 5-11112 Product Usage: Tracheal tube/airway management. Recalled by Teleflex Medical. Units affected: 7963 units.
Why was this product recalled? ▼
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, requiring medical intervention.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 18, 2019. Severity: Critical. Recall number: Z-2311-2019.
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