Medtronic Perfusion Systems: Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 W/CVR NI BB STERILE). The Affinity Pixie

Is my product affected?

Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 W/CVR NI BB STERILE). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extra

• UPC 20613994617303

Check against the official notice below — it lists the full affected range.

What happened

Medtronic is recalling 57 units of its Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (model BBP241, lot number 13340434) due to potentially elevated levels of bacterial endotoxin. These products were distributed worldwide, including throughout the United States and in 23 other countries. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.

The recall affects a specific lot of sterile oxygenators used in perfusion systems during cardiac procedures. The source document does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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: 57 units Lot/code info: Description: OXYGENATOR BBP241 W/CVR NI BB STERILE. Model Number: BBP241. GTIN: 20613994617303. Lot Number: 13340434.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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All FDA (Device enforcement) recalls