Medtronic recalls Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir due to potential bacterial endotoxin exposure causing acute inflammatory responses in patients.
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.
Medtronic is recalling its Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface because they may contain elevated levels of bacterial endotoxins. This could lead to serious health issues like acute inflammatory responses in patients using these devices during surgery.
The recalled devices may contain elevated levels of bacterial endotoxins, which can cause an acute inflammatory response in patients. This occurs when the body reacts to the endotoxins, potentially leading to serious health complications.
Patients undergoing surgery who use the recalled oxygenator and reservoir devices are at risk. Healthcare providers using these products in medical procedures may also be affected.
Check for the model number BBP241 on the device label. The product was sold with the lot number 13340434 and GTIN 20613994617303.
Look for the model number BBP241 on the device label to confirm if it is recalled.
The devices may contain elevated levels of bacterial endotoxins, which can cause an acute inflammatory response in patients.
Check for the model number BBP241 on the device label. The product was sold with the lot number 13340434 and GTIN 20613994617303.
The recall record does not specify a remedy, so contact Medtronic Perfusion Systems directly for guidance.
We’ve drafted a message you can send Medtronic Perfusion Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1191-2021 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-1191-2021 from Medtronic Perfusion Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
