FDA Device recall Z-3033-2018
Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized
- FDA Device
- Class II
- terminated
- Published 2018-09-19
On 2018-09-19 the FDA classified a Class II recall of Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, 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-3033-2018 |
| 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 Femoral Venous Cannula, 20F X 55CM, 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 VFEM020-R; Lot Number 59691447; Serial Number 16704032017-01 |
|---|
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-3033-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.