Medtronic recalls specific lots of Custom Pack HY8M63R4 Adult ECC perfusion systems due to potential incomplete welds. Affected units may have safety risks.
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic is recalling specific lots of Custom Pack HY8M63R4 Adult ECC perfusion systems because some units may have been manufactured with incomplete welds. This could pose a safety risk if the device fails during use.
Incomplete welds in the device could lead to failure during use, potentially causing safety issues. The hazard is related to the manufacturing process and may not be immediately obvious.
Patients using the Custom Pack HY8M63R4 Adult ECC perfusion system are likely affected. Those with the specific lot numbers mentioned in the recall are at the highest risk.
Check for the product name 'Custom Pack HY8M63R4 Adult ECC' and the lot number 221058527. The use-by date for affected units is October 30, 2022.
Look for the lot number 221058527 on the device packaging or label.
The recalled product is Medtronic Custom Pack HY8M63R4 Adult ECC perfusion system with lot number 221058527.
The recall record does not specify a remedy or action for this issue.
The recall states that specific lots may have incomplete welds, which could lead to safety issues during use.
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-1872-2021 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-1872-2021 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.
