Edwards Lifesciences recalls PediaSat Oximetry Catheter Kit (REF XT358SJ) due to potential internal leaks. This may cause complications during medical use. Affected units have specific lot numbers and are not distributed in the US.
There is a potential for internal leaks within catheters.
Edwards Lifesciences is recalling a specific PediaSat Oximetry Catheter Kit model due to a potential for internal leaks. This could lead to complications during medical procedures if the catheter leaks internally. The recall affects certain lot numbers sold outside the US.
The catheter may develop internal leaks, which could lead to complications during medical procedures. This risk is specific to the catheter's design and manufacturing process, potentially affecting patient safety during monitoring.
Healthcare providers and medical facilities using the Edwards PediaSat Oximetry Catheter Kit (REF XT358SJ) are likely affected. Patients receiving this catheter for medical monitoring are at risk if the leak causes complications.
Check for the model reference XT358SJ on the catheter kit. The kit has a usable length of 8 cm, three lumens, and an exterior diameter of 5.5F. It is not distributed within the US and comes with specific lot numbers.
Verify the model reference XT358SJ, usable length of 8 cm, three lumens, and exterior diameter of 5.5F on the catheter kit.
No, this catheter kit is not distributed within the US.
Affected lot numbers include 62374649, 62489899, 62505763, 62544662, 62728572, 62889053, 63045884, 63080087, 63105621, 63176482, 63256056, 63266249, 63350873, 63374025.
There is a potential for internal leaks within the catheters, which could lead to complications during medical procedures.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2280-2021 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-2280-2021 from Edwards Lifesciences. 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.
