Edwards Lifesciences Optisite Arterial Perfusion recall: Labeling Error
Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized.
Why was Edwards Lifesciences Optisite Arterial Perfusion 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 OPTI22-R; Lot Number 59637295; Serial Number 16502032017-01
- Product
- Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, 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)