Edwards recalls TruWave 3 cc/VAMP Jr Kit (REF: VMP426PX) due to potential pressure tubing detachment from blood sampling systems. Affected units have CE UDI: (01)57460691950547 and lot # 63598812.
There is a potential that the pressure tubing may detach from the blood sampling system
Edwards is recalling its TruWave 3 cc/VAMP Jr Kit (REF: VMP426PX) because the pressure tubing might detach from the blood sampling system. This could lead to inaccurate blood pressure readings or other 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 TruWave 3 cc/VAMP Jr Kit for blood pressure monitoring are likely affected. Patients receiving this kit during medical procedures may be at risk if tubing detaches.
Check for the product name 'Edwards TruWave 3 cc/VAMP Jr Kit', reference number VMP426PX, and CE UDI: (01)57460691950547. Lot number 63598812 is also associated with this recall.
Verify the product name, reference number, and CE UDI to confirm if your kit is affected.
The recall states there is a potential for pressure tubing to detach, which could lead to inaccurate blood pressure readings. However, the hazard is not described as causing serious injury in normal use.
Check for the product name 'Edwards TruWave 3 cc/VAMP Jr Kit', reference number VMP426PX, and CE UDI: (01)57460691950547. Lot number 63598812 is also associated with this recall.
The recall does not specify a remedy, so 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-1965-2021 — Edwards Edwards Hello, I own a Edwards that is covered by recall Z-1965-2021 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.
