Medtronic recalls specific lots of Custom Perfusion Systems for potential insufficient welding, which could lead to leaks. Affected units include lot 221196140 with use by date 2022-09-24.
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 cause leaks, potentially leading to serious complications if the device is used improperly.
The recall is for specific lots that may have been manufactured with insufficient or incomplete welds. This could lead to leaks in the device, which might cause serious complications if the system is used without proper integrity.
Patients using the Custom Perfusion System with lot number 221196140 (use by date 2022-09-24) are most at risk. Healthcare providers who have this specific model are also affected.
Check for the lot number 221196140 on the device packaging. The use by date for affected units is September 24, 2022. The product is labeled as Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.
Look for the lot number 221196140 on the product packaging or label.
The specific lot number for this recall is 221196140.
The use by date for affected units is September 24, 2022.
Check for the lot number 221196140 on the device packaging. The use by date for affected units is September 24, 2022.
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-1879-2021 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-1879-2021 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.
