Skip to content
Recall Observatory FDA recall evidence

Device product

Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized.

Z-3027-2018

March 07, 2018

Class II

Product summary

Firm
SPS Sterilization, Inc
Event
Event 80317
Status
Terminated
Classification
Class II
Quantity
10 units total
Official record key
device-enforcement:Z-3027-2018

Official wording

Reason: 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.

Code information: 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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.