FDA-Device2019-02-06Class II
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.
Medtronic Perfusion Systems
Hazard
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.
Sold states
Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, France, Germany, Japan, and Sweden.
Affected count
1100 units
Manufactured in
7611 Northland Dr N, N/A, Brooklyn Park, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0785-2019Don't want to check this manually?
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