Medtronic recalls Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B) due to potential elevated bacterial endotoxin levels that could cause 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 Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B) because it may contain elevated levels of bacterial endotoxins. This could lead to serious health issues like acute inflammatory responses in patients using the device during surgery.
The device may contain elevated levels of bacterial endotoxins, which can trigger an acute inflammatory response in patients. This risk occurs when the device is used during extracorporeal circulation procedures, such as heart surgery.
Patients undergoing surgery who use this specific blood collection device are at risk. Medical professionals using the device for extracorporeal circulation are most affected.
Check for the product name 'Perfusion M448036B 1/B' on the device label. The lot number 220798975 is associated with this recall.
Look for the product name 'Perfusion M448036B 1/B' and lot number 220798975 on the device.
The recall indicates potential elevated bacterial endotoxin levels that could cause health risks, so it should not be used until the recall is addressed.
Check the device label for the product name 'Perfusion M448036B 1/B' and lot number 220798975. Contact Medtronic for further instructions.
The recall states that patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response, which can be serious.
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-1194-2021 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-1194-2021 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.
