Edwards Lifesciences recalls PediaSat Oximetry Catheter Sets with potential internal leaks. Affected units have specific model and lot numbers. Contact for return instructions.
There is a potential for internal leaks within catheters.
Edwards Lifesciences is recalling PediaSat Oximetry Catheter Sets that may have internal leaks. This could lead to complications if used in medical procedures. Affected units have specific model and lot numbers.
Internal leaks in the catheter could cause fluid to escape during medical procedures. This might lead to complications like infection or inaccurate readings if the device is used improperly.
Parents or caregivers of infants using this catheter set for medical monitoring. Infants with specific medical conditions requiring this device are at higher risk.
Check for the model number XT3515SJ, exterior diameter 5.5F, and usable length 15 cm. The lot numbers 62489900, 62505764, 62544663, 62706301, 62714762, 62889054, 62889102, or 63091148 are affected.
Look for the model number XT3515SJ, exterior diameter 5.5F, and usable length 15 cm on the catheter set.
Reach out to Edwards Lifesciences for specific return or replacement instructions.
The product may have internal leaks, which could cause complications. It is recommended to stop using and contact Edwards Lifesciences for instructions.
Lot numbers 62489900, 62505764, 62544663, 62706301, 62714762, 62889054, 62889102, and 63091148 are affected.
Contact Edwards Lifesciences directly for replacement options after checking the product details.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2283-2021 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-2283-2021 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.
