Recall Z-0786-2019— Medtronic Perfusion Systems
Class II · Ongoing
Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2018-11-27. It names one FDA 510(k) clearance: K812292. Product: 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: 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..
- Recalling firm
- Medtronic Perfusion Systems
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2018-11-27
- Firm location
- Brooklyn Park, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.