SPS Sterilization, Inc: Medical Device Recall in 2018 - (Recall #: Z-3027-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 7, 2018

Date Posted: September 19, 2018

Recall Number: Z-3027-2018

Event ID: 80317

Reason for Recall:

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.

Status: Terminated

Product Quantity: 10 units total

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

Voluntary or Mandated:

Voluntary: Firm initiated