FDA-Device2019-02-06Class II

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.

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
7587 units
Manufactured in
7611 Northland Dr N, N/A, Brooklyn Park, MN, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0786-2019

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