Z-1759-2019 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 26, 2019
- Initiation Date
- May 24, 2019
- Termination Date
- February 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3483 units
Product Description
Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management
Reason for Recall
This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal tube.
Distribution Pattern
Worldwide - US Nationwide Distribution
Code Information
Lot Numbers: 73K1600369, 73L1600011, 73A1700646, 73C1700238, 73D1700625, 73E1700475, 73F1700387, 73H1700041, 73H1700483, 73J1700292, 73L1700503, 73M1700453, 73A1800671, 73B1800350, 73D1800138, 73F1800174, 73G1800126, 73G1800806, 73J1800308, 73K1800173, 73L1800225, 73K1800172