Edwards recalls TruWave (30 cc)/VAMP Jr/52 in (132 cm) Pressure Monitoring Kit due to potential pressure tubing detachment from blood sampling systems. Affected units have specific lot numbers and were sold with CE marking.
There is a potential that the pressure tubing may detach from the blood sampling system
Edwards is recalling a pressure monitoring kit used in medical settings because the tubing might detach from the blood sampling system. This could lead to inaccurate pressure readings or complications during medical procedures.
The pressure tubing in the kit may detach from the blood sampling system during use. This could cause inaccurate pressure readings or potential complications during medical procedures, though the risk is not described as causing serious injury.
Healthcare professionals using the Edwards TruWave Pressure Monitoring Kit for blood pressure monitoring in medical facilities. Patients receiving care with this equipment may be at risk if the tubing detaches.
Check for the kit's model number PXVJ0711, lot numbers 63470654, 63505217, or 63592430, and CE marking on the packaging. The kit is designed for medical use only and sterilized with ethylene oxide.
Verify the kit's model number (PXVJ0711) and lot numbers (63470654, 63505217, 63592430) to confirm if it's affected.
The recall states there is a potential for pressure tubing to detach, which could cause inaccurate readings or complications, but it does not specify a risk of serious injury.
Check for the model number PXVJ0711 and lot numbers 63470654, 63505217, or 63592430 on the packaging.
The recall does not provide specific action steps beyond checking the kit details; Edwards Lifesciences has not issued a remedy for this issue.
We’ve drafted a message you can send Edwards to request your refund or repair — edit it as you like.
Subject: Recall Z-1960-2021 — Edwards Edwards Hello, I own a Edwards that is covered by recall Z-1960-2021 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.
