Home / Recalls / Medical Devices
SPS Sterilization, Inc recalls Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized.
Recalled September 19, 2018 · FDA recall Z-3027-2018 · SPS Sterilization
Hazard
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. · FDA Class II
Units
10 units total
Sold at
US distribution to AZ, CA, FL, OH, PA, TX, VA, WV
Description
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.
Product
Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized.
Manufacturer(s)
SPS Sterilization, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →