SPS Sterilization, Inc: Medical Device Recall in 2018 - (Recall #: Z-3030-2018)

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 Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized.

Product Classification:

Class II

Date Initiated: March 7, 2018

Date Posted: September 19, 2018

Recall Number: Z-3030-2018

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: 5 units total

Code Information:

Code Number TF034L-R; Lot Number 59739865; Serial Numbers 18304192017-12, 18304192017-13, 18304192017-14, 18304192017-15, 18304192017-16

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated