Z-3034-2018 Class II Terminated
FDA device recall Z-3034-2018 was initiated by SPS Sterilization, Inc on March 7, 2018 and is designated Class II. 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. The recall status is terminated (terminated November 27, 2018). Affected quantity: 1 unit total.
Recall Details
- Product Type
- Devices
- Report Date
- September 19, 2018
- Initiation Date
- March 7, 2018
- Termination Date
- November 27, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit total
Product Description
Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized.
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 Pattern
US distribution to AZ, CA, FL, OH, PA, TX, VA, WV
Code Information
Code Number OPTI22-R; Lot Number 59637295; Serial Number 16502032017-01