Medtronic recalls specific lots of CB10R55R5 perfusion systems due to potential insufficient welds. Affected units may have safety risks requiring immediate action.
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic is recalling specific lots of CB10R55R5 perfusion systems because some units may have been manufactured with insufficient or incomplete welds. This could lead to safety issues if the device fails during use.
Insufficient or incomplete welds in the loop could cause the device to fail during use, potentially leading to safety issues. This is a manufacturing defect that may not be immediately obvious.
Patients using Medtronic CB10R55R5 perfusion systems with the specific lot numbers mentioned are affected. Those with the device in use are most at risk.
Check for the lot number 221542968 on the device packaging or label. The product was sold with a use-by date of November 6, 2022.
Look for the lot number 221542968 on the device packaging or label.
The specific lot number for this recall is 221542968.
This product was sold with a use-by date of November 6, 2022.
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-1888-2021 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-1888-2021 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.
