Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0786-2019 — 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.

U.S. FDA — Device Enforcement · United States · 2018-11-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0786-2019
Date of alert
2018-11-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medtronic Perfusion Systems
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10673978522545
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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