Edwards recalls TruWave (3 cc)/VAMP Jr Pressure Monitoring Sets with potential tubing detachment. Affected units have specific CE UDI and lot numbers. Contact for remedy.
There is a potential that the pressure tubing may detach from the blood sampling system
Edwards is recalling certain TruWave (3 cc)/VAMP Jr pressure monitoring sets due to a risk that the pressure tubing might detach from the blood sampling system. This could lead to inaccurate readings or complications during medical procedures.
The pressure tubing could detach from the blood sampling system, potentially causing inaccurate blood pressure readings. This might lead to incorrect medical decisions or complications during procedures.
Healthcare professionals using the Edwards TruWave (3 cc)/VAMP Jr pressure monitoring sets for blood pressure monitoring are most at risk. Patients receiving this equipment may also be affected if the tubing detaches during use.
Check for the CE UDI code (01)07460691958746 and lot number 63545959 on the product packaging. This specific model is sold under the Edwards TruWave (3 cc)/VAMP Jr name.
Look for the CE UDI code (01)07460691958746 and lot number 63545959 on the packaging.
The recall indicates a potential risk of tubing detachment, so it is not recommended for use until the remedy is applied.
The recall record does not specify a remedy, so contact Edwards Lifesciences directly for instructions.
Check for the CE UDI code (01)07460691958746 and lot number 63545959 on the packaging.
We’ve drafted a message you can send Edwards to request your refund or repair — edit it as you like.
Subject: Recall Z-1966-2021 — Edwards Edwards Hello, I own a Edwards that is covered by recall Z-1966-2021 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.
