Medtronic Perfusion Systems recalls SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated for use wit…

Recall date

November 27, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0786-2019

FDA classification

Class II

Brand / firm

Medtronic Perfusion Systems

Sold / distributed

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, France, Germany, Japan, and Sweden.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.