Edwards Lifesciences recalls PediaSat Oximetry Catheter Set (REF: XT358KTP) due to potential internal leaks. Affected units have specific lot numbers and dimensions. Consumers should contact Edwards for details.
There is a potential for internal leaks within catheters.
Edwards Lifesciences is recalling a specific PediaSat Oximetry Catheter Set model due to a potential for internal leaks. This could lead to complications if the catheter leaks during medical use.
Internal leaks in the catheter could cause medical complications if the device is used improperly. The leak might affect the accuracy of oxygen monitoring or lead to infection risks.
Parents or caregivers of infants using this catheter for medical monitoring are most at risk. The recall affects specific lot numbers of the PediaSat Oximetry Catheter Set.
Check the product's lot numbers: 62889103, 62939785, 62954623, 63435579, 63439594. The catheter has an exterior diameter of 5.5F and a usable length of 8 cm.
Reach out to Edwards Lifesciences for specific instructions on how to handle the recalled catheter set.
The recall indicates a potential for internal leaks, so it is not recommended for use until the manufacturer provides instructions.
Contact Edwards Lifesciences directly for guidance on the next steps.
Check the lot numbers: 62889103, 62939785, 62954623, 63435579, 63439594. The catheter has an exterior diameter of 5.5F and a usable length of 8 cm.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2282-2021 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-2282-2021 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.
