Medtronic recalls specific lots of Custom Perfusion Systems due to potential insufficient welds. Affected units may have safety risks requiring immediate attention.
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic is recalling specific lots of Custom Perfusion Systems because some units may have been manufactured with insufficient or incomplete welds. This could lead to safety issues if the system fails during use.
Insufficient welds in the Custom Perfusion System could cause leaks or failures during operation. This might lead to complications for patients if the system malfunctions while in use.
Patients using the Medtronic Custom Perfusion System with the specific lot numbers mentioned are affected. Those with the recalled units are at risk if the system fails during use.
Check for the lot numbers 221719701 (use by 2023-01-06) or 221764442 (use by 2023-01-13) on the product label. The product is a sterile, custom-pack Custom Perfusion System with GTIN 00763000499105.
Look for lot numbers 221719701 (use by 2023-01-06) or 221764442 (use by 2023-01-13) on the product label.
Specific lots may have been manufactured with insufficient or incomplete welds, which could lead to leaks or failures during use.
Check the product label for lot numbers 221719701 (use by 2023-01-06) or 221764442 (use by 2023-01-13).
The recall record does not specify a remedy, so contact Medtronic directly for guidance.
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-1891-2021 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-1891-2021 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.
