medical Class II Updated 2021-08-18

Edwards Lifesciences, LLC recalls Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable

Recalled Product

Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F, Rx Only, Sterile EO, UDI: (01)00690103197495 *NOT DISTRIBUTED WITHIN THE US


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: 62374649, 62489899, 62505763, 62544662, 62728572, 62889053, 63045884, 63080087, 63105621, 63176482, 63256056, 63266249, 63350873, 63374025
View official government recall

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