Medtronic recalls specific lots of Custom Perfusion Systems due to potential insufficient welds. Affected units may have safety risks; contact Medtronic for details.
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic is recalling specific lots of Custom Perfusion Systems that may have been manufactured with insufficient or incomplete welds. This could lead to safety issues if the device fails during use.
Insufficient welds in the device could cause it to fail during use, potentially leading to safety risks. The exact mechanism of failure is not clearly described in the recall notice.
Patients using the Custom Perfusion System with the specific lot numbers listed in the recall are affected. Those who have the device and are using it for medical purposes are at risk.
Check the lot numbers on your device: 220866430 (Use By 2022-04-03), 221102361 (Use By 2022-04-03), or 221727287 (Use By 2022-09-29). The product is a sterile, custom-pack Custom Perfusion System.
Look for the lot number on your device: 220866430, 221102361, or 221727287.
The recall states that specific lots may have been manufactured with insufficient or incomplete welds, which could lead to safety issues if the device fails during use.
Check the lot number on your device: 220866430 (Use By 2022-04-03), 221102361 (Use By 2022-04-03), or 221727287 (Use By 2022-09-29).
The recall does not specify a remedy, so contact Medtronic directly for further instructions.
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-1875-2021 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-1875-2021 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.
