FDA Device recall Z-1129-2023
HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
- FDA Device
- Class II
- ongoing
- Published 2023-02-22
On 2023-02-22 the FDA classified a Class II recall of HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002 by Access Vascular, citing select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1129-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-16 |
| Published | 2023-02-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Access Vascular |
| Distribution | US |
Product
HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
Reason
Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.
Identifiers
| code_info | UDI-DI: (01)00850030354006; Lot Number: 11428361, 11393260, 11395226 |
|---|
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-1129-2023%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.