FDA Device recall Z-0545-2023
STRADIS HEALTHCARE, Vein RF Pack, Item No.682-1942NL1
- FDA Device
- Class II
- ongoing
- Published 2022-12-21
On 2022-12-21 the FDA classified a Class II recall of STRADIS HEALTHCARE, Vein RF Pack, Item No.682-1942NL1 by Stradis Medical, citing medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0545-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-02 |
| Published | 2022-12-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stradis Medical |
| Distribution | US |
Product
STRADIS HEALTHCARE, Vein RF Pack, Item No.682-1942NL1,
Reason
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Identifiers
| code_info | UDI/DI (case) M7526821942NL11, UDI/DI (kit)M7526821942NL10, Serial/Lot Numbers: 22251491808 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0545-2023%22
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