RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 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 has recalled approximately 1,100 units of two models of reservoir "Y" adapters (BT920 and BT926) used in autotransfusion systems. The Y-connectors in the suction lines have been found to exhibit tearing and cracking, which could cause leaks during use, potentially resulting 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.
The recall affects specific lot numbers of both models. For BT920 units, the affected lot numbers are 216044420, 216062719, and 216438180. For BT926 units, the affected lot numbers are 215782209, 215903433, 216034158, 216107790, 216372963, and 216438301. The source document does not specify what actions affected consumers should take in response to this recall.
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: 1100 units Lot/code info: BT920: GTIN/UDI Lot/Serial Numbers 10673978522460 216044420 10673978522460 216062719 10673978522460 216438180 BT926: GTIN/UDI Lot/Serial Numbers 10673978522477 215782209 10673978522477 215903433 10673978522477 216034158 10673978522477 216107790 10673978522477 216372963 10673978522477 216438301
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.