Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Edwards Lifesciences Femoral Venous Cannula Recalled by SPS Sterilization, Inc Due to The expiration date on the device labeling exceeds...

Date: March 7, 2018
Company: SPS Sterilization, Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact SPS Sterilization, Inc directly.

Affected Products

Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized.

Quantity: 1 unit total

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 8 states: AZ, CA, FL, OH, PA, TX, VA, WV

Affected (8 states)Not affected

About SPS Sterilization, Inc

SPS Sterilization, Inc has 15 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report