SPS Sterilization, Inc: Medical Device Recall in 2018 - (Recall #: Z-3034-2018)

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 Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized.

Product Classification:

Class II

Date Initiated: March 7, 2018

Date Posted: September 19, 2018

Recall Number: Z-3034-2018

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: 1 unit total

Code Information:

Code Number OPTI22-R; Lot Number 59637295; Serial Number 16502032017-01

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated