Edwards Lifesciences Thin-Flex Single Stage Venous recall: Labeling Error
Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized.
Why was Edwards Lifesciences Thin-Flex Single Stage Venous 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 TF038L-R; Lot Number 59634935; Serial Numbers 18302172017-01, 18302172017-02, 18302172017-03, 18302172017-04, 18302172017-05, 18302172017-06, 18302172017-07, 18302172017-08, 18302172017-09, 18302172017-10
- Product
- Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized.
- Recalling firm
- SPS Sterilization, Inc
- Quantity
- 10 units 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)