Edwards Lifesciences recalls TruWave Pressure monitoring sets with potential flushing difficulties during setup with pressure transducer. Affected models include PX212, PX260, PX272, PX284, and others. Contact for remedy details.
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Edwards Lifesciences is recalling certain TruWave Pressure monitoring sets due to a potential risk of flushing difficulties when setting up the pressure monitoring kit with a pressure transducer. This could affect medical use and requires attention to prevent complications.
The pressure monitoring kit may cause flushing difficulties during setup with the pressure transducer. This could lead to improper function of the monitoring system, potentially affecting medical readings and patient safety.
Patients using these pressure monitoring sets for medical purposes are most at risk. Healthcare providers who use the devices for clinical monitoring may also be affected.
Check for model numbers like PX212, PX260, PX272, PX284, PX2X2, PX3X3284C, PX4X4, PX600F, PXMK1876, PXMK1940, PXMK2024, PXMK2041, PXMK2321, PXMK2331, PXMK9146, PXMK0102, PXMK2043, T001657A, T001658A, T001660A, T001709A, T001767A, T321573A, T433803A, T441T01C, T494C00B. The product was sold with specific sizes and lot numbers as listed in the recall notice.
Identify your TruWave Pressure monitoring set model number (e.g., PX212, PX260, PX272) to confirm if it's affected.
Reach out to Edwards Lifesciences for specific instructions on how to handle the affected product.
Affected models include PX212, PX260, PX272, PX284, PX2X2, PX3X3284C, PX4X4, PX600F, PXMK1876, PXMK1940, PXMK2024, PXMK2041, PXMK2321, PXMK2331, PXMK9146, PXMK0102, PXMK2043, T001657A, T001658A, T001660A, T001709A, T001767A, T321573A, T433803A, T441T01C, and T494C00B.
The recall notice does not specify a remedy. Contact Edwards Lifesciences for instructions.
The hazard is potential flushing difficulties during setup with the pressure transducer, which could affect medical monitoring.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0413-2024 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-0413-2024 from Edwards Lifesciences. 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.
