FDA Recall
Terminated
Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.
Recall: Z-3028-2018
·
Initiated March 7, 2018
Recall
- Recall Number
- Z-3028-2018
- Event Number
- 80317
- Firm
- SPS Sterilization, Inc
- FEI Number
- 3005057969
- Product Code
- DWF
- Status
- Terminated
- Root Cause
- Labeling False and Misleading
- Initiated
- March 7, 2018
- Terminated
- November 27, 2018
- Address
- 1110 N Gerald St, Nixa, MO, 65714-7445
Description
Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.
Reason
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.
Action
Customers were notified via letter on about 03/02/2018. Instructions included to review inventory for affected devices, arrange for their return to SPS Sterilization, and complete and return the Buisness Response Card. A follow up letter was sent to customer on about 03/07/2018 and included a description of the risk and hazard involved. Instructions remained the same.
Distribution
US distribution to AZ, CA, FL, OH, PA, TX, VA, WV
Quantity
6 units total