medical Class II Updated 2021-08-18

Edwards Lifesciences, LLC recalls Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exte

Recalled Product

Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, 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)00690103197563


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: 63522902 AND 63608320
View official government recall

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