SPS Sterilization, Inc recalls Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22
Recalled Product
Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, 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 OPTI22-R; Lot Number 59637295; Serial Number 16502032017-01
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