Medtronic recalls specific lots of Custom Perfusion Systems due to potential insufficient welds that could cause leaks. Affected units include lot 221332879 with use by date 2022-10-05.
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic is recalling specific lots of Custom Perfusion Systems because some units may have been manufactured with insufficient or incomplete welds. This could lead to leaks, which might cause serious complications for users.
Insufficient or incomplete welds in the Custom Perfusion System could result in leaks. Leaks might cause serious complications such as infection or other health issues for patients using the device.
Patients using the Medtronic Custom Perfusion System with the specific lot number 221332879 are most at risk. This recall affects individuals who have received the sterile, prescription-based product with the use by date of 2022-10-05.
Check for the lot number 221332879 on the product label. The product was sold with a use by date of 2022-10-05 and is part of the Medtronic CB10W65R1 Custom Perfusion System.
Look for the lot number 221332879 on the product label to confirm if it is affected.
The specific lot number for this recall is 221332879.
This product was sold with a use by date of 2022-10-05.
The recall does not require immediate stop use; however, you should check the lot number to determine if your product is affected.
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-1884-2021 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-1884-2021 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.