medical Class II Updated 2021-08-18

Edwards Lifesciences, LLC recalls Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exter

Recalled Product

Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197532


Hazard / Issue

There is a potential for internal leaks within catheters.

Issued by

FDA

Affected States: CA, TX, FL, AZ, PA, IN, NY, NJ, MI, WA, MD, OH
Lot/Code Info: LOT NUMBERS: 62685549, 62728569, 62889136, 62903838, 63256058, 62728569, 62889136, 62903838, 62939833, 62452820, 62661574, 62420335, 62889136, 63256058, 62452820, 62661574, 62685549, 62728569, 62420335, 62420335, 62452820, 62420335, 62452820, 62661574, 62889136, 62903838, 63600994, 63608318, 63608323, 62661574, 62420335, 62661574, 62903838
View official government recall

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