Edwards recalls specific pressure monitoring kits for potential tubing detachment during blood sampling. This recall applies to CE-marked kits sold outside the US with UDI 01 57460691930174. No action is required as the kits are not marketed in the US.
There is a potential that the pressure tubing may detach from the blood sampling system
Edwards is recalling a specific pressure monitoring kit used for blood sampling that may detach the pressure tubing. This could cause injury during medical procedures. The kits are not sold in the US, so no action is needed for US customers.
The pressure tubing might detach from the blood sampling system during use, potentially causing injury. This risk occurs in medical procedures where the tubing is connected to a patient's blood flow.
Patients using this specific pressure monitoring kit for blood sampling in medical settings outside the US. US customers are not affected as the kits are not marketed there.
Check for the kit name 'Edwards TruWave x2 (3 cc)/VAMP Jr/54 in (136) Kit' with reference number T443952B. The kits are CE-marked and sterilized with ethylene oxide. They were not marketed in the US.
Look for the reference number T443952B and CE marking on the kit packaging.
No, the kits are not marketed within the US.
No action is required as the kits are not sold in the US.
The tubing might detach during blood sampling, potentially causing injury.
We’ve drafted a message you can send Edwards to request your refund or repair — edit it as you like.
Subject: Recall Z-1961-2021 — Edwards Edwards Hello, I own a Edwards that is covered by recall Z-1961-2021 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.
