medical Class II Updated 2018-09-19

SPS Sterilization, Inc recalls Edwards Lifesciences Femoral Venous Cannula, 18FR, resterili

Recalled Product

Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized.


Hazard / Issue

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

Issued by

FDA

Affected States: AZ, CA, FL, OH, PA, TX, VA, WV
Lot/Code Info: Code Number VFEM018-R; Lot Number 59740463; Serial Number 16704192017-01
View official government recall

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