Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). 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 with th
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 70 units of its Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface, a single-use medical device used in perfusion systems. The devices are being recalled because they may contain elevated levels of bacterial endotoxin. The affected lot number is 220265395, and the devices were distributed worldwide, including throughout the United States and in countries such as the United Kingdom, Germany, Japan, China, and others.
Patients exposed to elevated levels of bacterial endotoxins from these devices may develop an acute inflammatory response. 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.
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: 70 units Lot/code info: Description: CUSTOM PACK BB10H89R4 ECLR. Model Number: BB10H89R4. GTIN: 00763000126315. Lot Number: 220265395.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.