FDA Device recall Z-0742-2018
Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015)
- FDA Device
- Class II
- terminated
- Published 2018-03-07
On 2018-03-07 the FDA classified a Class II recall of Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015) by Angiodynamics, citing product was placed into distribution prior to completion of all required post sterilization release activities.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0742-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-22 |
| Published | 2018-03-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Angiodynamics |
| Distribution | AL, CA, CT, FL, GA, IL, IN, MD, MI, MN, MO, OH, OR, TX |
Product
Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.
Reason
Product was placed into distribution prior to completion of all required post sterilization release activities.
Identifiers
| code_info | Lot Number: 5229642; Manufactured 6-Sep-17; Expiration Date: 31-Aug-20 |
|---|
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-0742-2018%22
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