Reported Aug 18, 2021 · Terminated
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of…
Edwards Lifesciences, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edwards Lifesciences, LLC · 1 Edwards Way · Irvine, CA · 92614-5688
Is this the product you have?
- Edwards PediaSat Oximetry Catheter Kit
- REF
XT3515SPExterior Diameter 5.5F (1.83 mm)Usable Length 15 cmNumber of Lumens 3Recommended Guidewire Size 0.025" (0.64 mm)Rx OnlySterile EO
- UDI(01)00690103197532
- Lot codes and dates
- LOT NUMBERS
626855496272856962889136629038386325605862728569628891366290383862939833624528206266157462420335628891366325605862452820626615746268554962728569624203356242033562452820624203356245282062661574628891366290383863600994636083186360832362661574624203356266157462903838
- LOT NUMBERS
- Amount recalled
- 200 UNITS
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
There is a potential for internal leaks within catheters.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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