Medtronic recalls infant tubingsets due to potential bacterial endotoxin levels that could cause acute inflammatory responses in patients. Affected units include specific model and lot numbers.
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 infant tubingsets that may contain elevated bacterial endotoxins. This could lead to acute inflammatory responses in patients using the device. The recall affects specific model numbers and lot ranges.
The tubingsets may contain elevated levels of bacterial endotoxins. When patients are exposed to these endotoxins, they can develop an acute inflammatory response, which is a serious medical reaction.
Infants receiving extracorporeal circulation treatment using the recalled tubingsets are most at risk. Healthcare providers using these devices for neonatal care may also be affected.
Check for the model number M483203D on the tubingset packaging. The affected lot numbers are 220781539 and 220887101. These units were sold with the specific product description.
Identify the model number M483203D and lot numbers 220781539 or 220887101 on the tubingset packaging.
The model number is M483203D.
Lot numbers 220781539 and 220887101 are affected.
The recall record does not specify a remedy.
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-1193-2021 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-1193-2021 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.
