🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: March 7, 2018 SPS Sterilization Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
SPS Sterilization, Inc
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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:

Distributed in: US, AZ, CA, FL, OH, PA, TX, VA, WV

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-3027-2018

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