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.
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 7,587 units of suction and anticoagulation assemblies (models BTC93 and BTC98) used with autotransfusion systems. The recall was initiated because certain Y-connectors in the suction lines have been found to tear and crack, which can cause leaks during use and potentially result in blood loss and a breach in the circuit.
The affected products were distributed worldwide, including throughout the United States and in Australia, Canada, France, Germany, Japan, and Sweden. Consumers can identify recalled units by checking the lot and serial numbers provided in the recall notice. The record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, France, Germany, Japan, and Sweden. Quantity: 7587 units Lot/code info: BTC93: GTIN/UDI Lot/Serial Numbers 10673978522545 215691544 10673978522545 215691545 10673978522545 215737228 10673978522545 215737229 10673978522545 215782206 10673978522545 215782207 10673978522545 215816859 10673978522545 215816860 10673978522545 215857423 10673978522545 215857424 10673978522545 215903431 10673978522545 215946277 10673978522545 216245142 10673978522545 215875581 10673978522545 215875582 10673978522545 215875583 10673978522545 216045172 10673978522545 216062720 10673978522545 216107788 10673978522545 216150361 10673978522545 216199988 10673978522545 216238209 10673978522545 216245141 10673978522545 216372965 10673978522545 216372966 10673978522545 216372967 10673978522545 216421235 10673978522545 216421236 10673978522545 216438179 BTC98: GTIN/UDI Lot/Serial Numbers 10673978522576 215782205 10673978522576 215903430 10673978522576 216034160 10673978522576 216062718 10673978522576 216238210
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.