Medtronic recalls 48 specific perfusion kit models due to endotoxin testing not being conducted, which may pose a risk of infection in medical use.
Product is labeled as non-pyrogenic but endotoxin testing was not performed.
Medtronic is recalling 48 different perfusion kit models because they were labeled as non-pyrogenic but endotoxin testing wasn't done. This could lead to infections in medical procedures if used improperly.
These kits were labeled as non-pyrogenic (free from harmful proteins) but endotoxin testing wasn't performed. Endotoxins are bacterial components that can cause infections if introduced into the body during medical procedures.
Healthcare professionals using these kits for medical treatments, particularly those in neonatal or pediatric care. Patients receiving transfusions or other medical procedures using these kits are at risk of infection.
Check for the model numbers listed in the recall: BB10Q85R, BB11C01R, B7H95R22, and others. Look for specific lot numbers and GTINs provided in the recall notice.
Identify the model number and lot numbers from the recall list to confirm if your kit is affected.
The recall record states that endotoxin testing was not performed, but does not explain why.
Check the model number and lot numbers against the list provided in the recall notice.
The recall record shows no remedy was specified.
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-0491-2022 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-0491-2022 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.
