Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized.
Check against the official notice below — it lists the full affected range.
SPS Sterilization, Inc. is recalling Edwards Lifesciences Aortic Perfusion Cannula devices (24F x 30CM, resterilized) because the expiration date printed on the device labeling extends beyond the actual validated shelf life of the product. The sterilization process used does not provide adequate support for the extended shelf life claimed on the label. A total of 10 units were distributed across Arizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia, and West Virginia.
The affected devices are identified by Code Number AAO24TFA-R and Lot Number 59736014, with serial numbers ranging from 16504192017-01 through 16504192017-10. The recall notice does not specify what remedy consumers or healthcare facilities should take regarding these devices.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: US distribution to AZ, CA, FL, OH, PA, TX, VA, WV Quantity: 10 units total Lot/code info: Code Number AAO24TFA-R; Lot Number 59736014; Serial Numbers 16504192017-01, 16504192017-02, 16504192017-03, 16504192017-04, 16504192017-05, 16504192017-06, 16504192017-07, 16504192017-08, 16504192017-09, 16504192017-10
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.