SPS Sterilization, Inc recalls Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized.

Recall date

March 7, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3034-2018

FDA classification

Class II

Brand / firm

SPS Sterilization, Inc

Sold / distributed

US distribution to AZ, CA, FL, OH, PA, TX, VA, WV

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized.