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Recall Observatory FDA recall evidence

Device product

Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management

Z-1759-2019

May 24, 2019

Class I

Product summary

Firm
Teleflex Medical
Event
Event 82964
Status
Terminated
Classification
Class I
Quantity
3483 units
Official record key
device-enforcement:Z-1759-2019

Official wording

Reason: 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.

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

Distribution pattern: Worldwide - US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.