medical Class II Updated 2021-08-18

Edwards Lifesciences, LLC recalls Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exter

Recalled Product

Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length 8 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197556

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: 62889103, 62939785, 62954623, 63435579, 63439594
View official government recall

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