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.
Reported: February 6, 2019 Initiated: November 27, 2018 #Z-0786-2019
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Medtronic Perfusion Systems
- Units Affected
- 7587 units
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, France, Germany, Japan, and Sweden.
- Location
- Brooklyn Park, MN
Frequently Asked Questions
What product 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.. Recalled by Medtronic Perfusion Systems. Units affected: 7587 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 6, 2019. Severity: Moderate. Recall number: Z-0786-2019.
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