Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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 EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.
Product Codes/Lot Numbers:
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:
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.govFDA Recall Number: Z-3028-2018
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