Medtronic recalls specific lots of Custom Perfusion Systems for potential insufficient welds that could cause leaks. Affected units include lot 220776249 with use by date 2022-07-06.
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic is recalling certain Custom Perfusion Systems due to a risk of leaks from insufficient or incomplete welds. This could lead to improper medical treatment if the device fails during use.
The device may have been manufactured with welds that are too weak or incomplete, potentially causing leaks. This could lead to improper medical treatment if the device fails during use.
Patients using the Custom Perfusion System with lot number 220776249 (use by date 2022-07-06) are most at risk. Healthcare providers who use this device may also be affected.
Check for the lot number 220776249 on the device packaging. The use by date for affected units is July 6, 2022. The product is a Custom Perfusion System with GTIN 00763000108328.
Look for the lot number 220776249 on the device packaging or label.
The recalled device is the Medtronic CB1H18R20 Custom Perfusion System with lot number 220776249.
The use by date for affected units is July 6, 2022.
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-1878-2021 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-1878-2021 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.
