Medtronic recalls specific lots of neonatal perfusion systems due to potential insufficient welds. Affected units may require replacement to prevent leaks or failures during medical use.
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic is recalling specific lots of neonatal perfusion systems because some units may have been manufactured with insufficient or incomplete welds. This could lead to leaks or failures during medical use, potentially causing harm to infants.
The perfusion system is used to support newborns with certain medical conditions. If welds are insufficient or incomplete, the system could leak or fail during use, potentially causing harm to the infant.
Parents and caregivers of newborns using Medtronic's Custom Perfusion System. Infants receiving medical treatment with this device are most at risk.
Check for the lot number 221387901 on the device packaging. The product was sold with a use-by date of December 16, 2022, and has a GTIN of 00643169947436.
Look for the lot number 221387901 on the packaging to confirm if your unit is affected.
No, only specific lots with lot number 221387901 are affected.
Check the lot number on the packaging. If it matches 221387901, contact Medtronic for further instructions.
The recall is due to potential insufficient welds, which could lead to leaks or failures during medical use. However, the remedy is not specified in the record.
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-1895-2021 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-1895-2021 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.
