Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 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 defoame
Check against the official notice below — it lists the full affected range.
Medtronic is recalling the Perfusion M484901D 1/B, a pediatric perfusion set component used in heart-lung bypass procedures. The recall affects 4 units with lot number 220906731 distributed worldwide, including throughout the US and in countries such as Japan, Germany, the United Kingdom, China, and others. The products are being recalled because they may contain elevated levels of bacterial endotoxin.
Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response. The source record does not specify a remedy or recommended action for consumers.
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: PERFUSION M484901D 1/B. Model Number: M484901D. GTIN: 00763000240288. Lot Number: 220906731.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.