Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B). 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 d
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 5 units of the Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface (Model Number M490817B, Lot Number 220886950) used in perfusion systems. The products are being recalled because they may contain potentially elevated levels of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
The affected products were distributed worldwide, including in the United States and 24 other countries and regions. The recall record 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: 5 units Lot/code info: Description: PERFUSION M490817B 1/B. Model Number: M490817B. GTIN: 00643169096271. Lot Number: 220886950.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.