SPS Sterilization, Inc: Medical Device Recall in 2018 - (Recall #: Z-3028-2018)

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 EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.

Product Classification:

Class II

Date Initiated: March 7, 2018

Date Posted: September 19, 2018

Recall Number: Z-3028-2018

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: 6 units total

Code Information:

Code Number EZC24A-R; Lot Number 59634962; Serial Numbers 16401032017-01, 16401032017-02, 16401032017-03, 16401032017-04, 16401032017-05, 16401032017-06, 16401032017-07, 16401032017-08, 16401032017-09, 16401032017-10, 16401032017-11, 16401032017-12, 16401032017-13, 16401032017-14, 16401032017-15, 16401032017-16, 16401032017-17, 16401032017-18, 16401032017-19, 16401032017-20, 16401032017-21, 16401032017-22, 16401032017-23, 16401032017-24, 16401032017-25, 16401032017-26, 16401032017-27, 16401032017-28, 16401032017-29, 16401032017-30, 16401032017-31, 16401032017-32, 16401032017-33, 16401032017-34, 16401032017-35, 16401032017-36, 16401032017-37

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated