Edwards recalls specific TruWave pressure monitoring kits due to potential tubing detachment from blood sampling systems. Affected kits have REF PXVJ356 and lots 63505216/63590: stop using immediately to prevent injury.
There is a potential that the pressure tubing may detach from the blood sampling system
Edwards is recalling certain Tru:Wave pressure monitoring kits because the tubing might detach during blood sampling. This could cause injury if the tubing disconnects while being used. Affected kits have specific model and lot numbers.
The pressure tubing could detach from the blood sampling system during use. This might cause blood loss or injury if the tubing disconnects while being used in medical procedures.
Healthcare professionals using the Edwards TruWave kits for blood pressure monitoring are most at risk. Patients receiving these kits during medical procedures may also be affected.
Check for the model reference PXVJ356 on the kit. Look for lot numbers 63505216 or 63590087 on the packaging or label.
Immediately stop using the Edwards TruWave kit if it has the model reference PXVJ356 and lot numbers 63505216 or 63590087.
No, this recall is for medical use only (RX Only) as indicated in the product description.
Check the model reference (PXVJ356) and lot numbers (63505216 or 63590087) on the kit packaging.
Stop using the kit 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-1959-2021 — Edwards Edwards Hello, I own a Edwards that is covered by recall Z-1959-2021 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.
