medical Class II Updated 2019-02-06

Medtronic Perfusion Systems recalls RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and

Recalled Product

RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.

Hazard / Issue

Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and cracking. These defects could cause the Y-connectors to leak when in use, which could result in potential blood loss and a breach in the circuit.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: BT920: GTIN/UDI Lot/Serial Numbers 10673978522460 216044420 10673978522460 216062719 10673978522460 216438180 BT926: GTIN/UDI Lot/Serial Numbers 10673978522477 215782209 10673978522477 215903433 10673978522477 216034158 10673978522477 216107790 10673978522477 216372963 10673978522477 216438301
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