Edwards Lifesciences Femoral Venous Cannula recall: Labeling Error
Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized.
Why was Edwards Lifesciences Femoral Venous Cannula 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Code Number VFEM018-R; Lot Number 59740463; Serial Number 16704192017-01
- Product
- Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized.
- Recalling firm
- SPS Sterilization, Inc
- Quantity
- 1 unit total
- Distribution
- US distribution to AZ, CA, FL, OH, PA, TX, VA, WV
- Recall date
- September 19, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)