Edwards Lifesciences recalls PediaSat Oximetry Catheter Kit (REF: XT3515SP) 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 their PediaSat Oximetry Catheter Kit (REF: XT3515SP) because it may have internal leaks. This could lead to complications during medical procedures if used improperly.
The catheter kit may have internal leaks, which could cause complications during medical procedures if used improperly. This risk is related to the device's design and manufacturing process.
Patients and healthcare providers using the Edwards PediaSat Oximetry Catheter Kit for medical procedures. Those with the specific lot numbers listed in the recall are most at risk.
Check the product label for the reference number XT3515SP, exterior diameter 5.5F (1.83 mm), and usable length 15 cm. Affected units have specific lot numbers listed in the recall notice.
Look for the reference number XT3515SP, exterior diameter 5.5F (1.83 mm), and usable length 15 cm on the catheter kit.
Reach out to Edwards Lifesciences for further instructions on the recall and to confirm if your unit is affected.
The recalled model is Edwards PediaSat Oximetry Catheter Kit with reference number XT3515SP.
Check the product label for the reference number XT3515SP, exterior diameter 5.5F (1.83 mm), and usable length 15 cm. Affected units have specific lot numbers listed in the recall notice.
Contact Edwards Lifesciences for further instructions on the recall and to confirm if your unit is affected.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2279-2021 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-2279-2021 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.
