Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). 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 before mixin
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 3 units of its Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR), which includes the Affinity Pixie Cardiotomy/Venous Reservoir, a single-use device. The recall was initiated because these products may contain potentially elevated levels of bacterial endotoxin. Patients exposed to elevated endotoxin levels may develop an acute inflammatory response.
The affected devices were distributed worldwide to numerous countries including the United States, Canada, and various nations in Europe, Asia, the Middle East, and South America. The specific recalled lot is number 220768819 with model number HY10J00R6 and GTIN 00763000304928. The source document does not specify what actions affected consumers should take.
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: 3 units Lot/code info: Description: CUSTOM PACK HY10J00R6 ECC SMALL CAR. Model Number: HY10J00R6. GTIN: 00763000304928. Lot number: 220768819.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.