Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). 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 mixing wit
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 7 units of the Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON), which includes the Affinity Pixie Cardiotomy/Venous Reservoir, due to potentially elevated levels of bacterial endotoxin. Patients exposed to elevated endotoxin levels may develop an acute inflammatory response. The affected lot number is 220911945, and these products were distributed worldwide to multiple countries including the United States, Japan, Germany, United Kingdom, and others.
The recall notice does not specify what action affected consumers or healthcare facilities should take in response to 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: 7 units Lot/code info: Description: CUSTOM PACK BB7W03R8 CCSM NEON. Model Number: BB7W03R8. GTIN: 00643169990562. Lot Number: 220911945.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.