Medtronic recalls Custom Perfusion System (BB10H89R4 ECLR) due to potential bacterial endotoxin levels that may 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 Perfusion System (BB10H89R4 ECLR) because it may contain elevated 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 acute inflammatory responses in patients. This is a serious risk during surgical procedures where blood is circulated outside the body.
Patients undergoing surgery using this specific perfusion system are at risk. Healthcare providers using the device for extracorporeal circulation may also be affected.
Check for the model number BB10H89R4 ECLR on the device packaging or label. The product was sold with the lot number 220265395.
Look for the model number BB10H89R4 ECLR and lot number 220265395 on the device packaging or label.
The model number is BB10H89R4 ECLR.
Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
Check for the model number BB10H89R4 ECLR and lot number 220265395 on the device packaging or label.
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-1196-2021 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-1196-2021 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.
