Z-1759-2019 Class I Terminated
FDA device recall Z-1759-2019 was initiated by Teleflex Medical on May 24, 2019 and is designated Class I. 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 beco… The recall status is terminated (terminated February 15, 2022). Affected quantity: 3483 units.
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