medical Class II Updated 2018-09-19

SPS Sterilization, Inc recalls Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, r

Recalled Product

Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, 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 AAO24TFA-R; Lot Number 59736014; Serial Numbers 16504192017-01, 16504192017-02, 16504192017-03, 16504192017-04, 16504192017-05, 16504192017-06, 16504192017-07, 16504192017-08, 16504192017-09, 16504192017-10
View official government recall

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