Edwards Lifesciences recalls blood management systems with potential pressure tubing detachment. Affected units have specific UDI and lot numbers. Stop using immediately to prevent injury.
There is a potential that the pressure tubing may detach from the blood sampling system
Edwards Lifesciences is recalling a blood management system that may have pressure tubing that detaches. This could cause injury during blood sampling procedures. Affected units have a specific UDI and lot number. Users should stop using the device immediately.
The pressure tubing might detach from the blood sampling system during use. This could lead to blood loss or injury if the tubing disconnects while a patient is being treated. The device is designed for single-use medical procedures.
Healthcare professionals using the Edwards blood management system for blood sampling are most at risk. Patients receiving this device during medical procedures may also be affected.
Check for the UDI code (01)57460691951520 and lot number 63456332 on the device packaging. This blood management system is sold under the Edwards brand for medical use only.
Discontinue use of the Edwards blood management system with the UDI (01)57460691951520 and lot number 63456332.
No, the Edwards blood management system with the specific UDI and lot number may have a risk of pressure tubing detachment, which could cause injury. Do not use it.
Check for the UDI code (01)57460691951520 and lot number 63456332 on the device packaging. This blood management system is sold for medical use only.
Stop using the device immediately and contact Edwards Lifesciences for further instructions.
We’ve drafted a message you can send Edwards to request your refund or repair — edit it as you like.
Subject: Recall Z-1962-2021 — Edwards Edwards Hello, I own a Edwards that is covered by recall Z-1962-2021 from Edwards. 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.
