Medtronic recalls specific lots of Custom Perfusion Systems with potential insufficient welds. Affected units may have safety risks; contact for remedy 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.
The device may have insufficient or incomplete welds, which could lead to failure during use. This might cause the device to malfunction or become unsafe if the welds are not properly sealed.
Patients using the Custom Perfusion System with the specific lot numbers mentioned in the recall are affected. Those with the product and the lot number 221387881 are most at risk.
Check for the lot number 221387881 on the product label. The product is labeled as Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Sterile, Rx.
Look for the lot number 221387881 on the product label to confirm if it is affected.
The specific lot number for this recall is 221387881.
Check for the lot number 221387881 on the product label. The product is labeled as Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Sterile, Rx.
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-1885-2021 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-1885-2021 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.
