Edwards Lifesciences recalls PediaSat Oximetry Catheter Kit (REF XT3515KTP) due to potential internal leaks. Affected units have specific lot numbers and dimensions. Consumers should check their product details and follow official instructions.
There is a potential for internal leaks within catheters.
Edwards Lifesciences is recalling a specific oximetry catheter kit because it may have internal leaks. This could lead to complications if used in medical procedures. Affected kits have a unique reference number and lot numbers.
The catheter kit may have internal leaks, which could cause complications during medical procedures. This risk is particularly concerning for patients who require precise monitoring of oxygen levels, such as infants and children.
Patients and healthcare providers using the Edwards PediaSat Oximetry Catheter Kit with reference number XT3515KTP are likely affected. Children and infants receiving medical care through this kit are at higher risk due to the potential for leaks.
Check for the reference number XT3515KTP on the product label. Affected kits have exterior diameter 5.5F (1.83 mm) and usable length 15 cm. Lot numbers 63522902 and 63608320 are also associated with this recall.
Look for the reference number XT3515KTP, exterior diameter 5.5F (1.83 mm), and usable length 15 cm on the catheter kit.
The recall indicates a potential for internal leaks, so it is not recommended for use until the remedy is applied. Edwards Lifesciences has not provided a specific remedy for this recall.
Lot numbers 63522902 and 63608320 are affected by this recall.
Check the reference number XT3515KTP, exterior diameter 5.5F (1.83 mm), and usable length 15 cm on the product label. Also, verify the lot numbers 63522902 and 63608320.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2278-2021 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-2278-2021 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.
