Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed befo
Check against the official notice below — it lists the full affected range.
Medtronic is recalling the Custom Perfusion Pack (Model HY11B40R1, Lot Number 220911913), which includes the Affinity Pixie Cardiotomy/Venous Reservoir with Balance Biosurface. Four units of this single-use device were distributed worldwide, including throughout the United States and in countries such as the United Kingdom, Germany, Japan, China, and others. The recall was initiated because the products may contain elevated levels of bacterial endotoxin.
Patients who were exposed to elevated levels of bacterial endotoxins during use of these devices may develop an acute inflammatory response. The recall record does not specify what consumers or healthcare providers should do regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
Reason for recall: Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response. Distribution: Worldwide distribution: US nationwide, Afghanistan, Argentina, Chile, China, Colombia, Egypt, Germany, Iraq, Italy, Japan, Korea, Kyrgyzstan, Latvia, Nicaragua, Paraguay, Poland, Qatar, Romania, Tanzania, United Arab Emirates, United Kingdom, Uzbekistan, and Viet Nam Quantity: 4 units Lot/code info: Description: CUSTOM PACK HY11B40R1 1/4 RESPIRATO. Model Number: HY11B40R1. GTIN: 00763000314231. Lot Number: 220911913.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.