FDA Device recall Z-3034-2018
Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized
- FDA Device
- Class II
- terminated
- Published 2018-09-19
On 2018-09-19 the FDA classified a Class II recall of Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized by Sps Sterilization, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3034-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-07 |
| Published | 2018-09-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Sps Sterilization |
| Distribution | AZ, CA, FL, OH, PA, TX, VA, WV |
Product
Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, 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.
Identifiers
| code_info | Code Number OPTI22-R; Lot Number 59637295; Serial Number 16502032017-01 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3034-2018%22
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