FDA Device recall Z-1021-2025
Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal space and epidural s…
- FDA Device
- Class II
- ongoing
- Published 2025-02-05
On 2025-02-05 the FDA classified a Class II recall of Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal space and epidural s… by B Braun Medical, citing incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter. The incorrect catheter connector is smaller than the re….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1021-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-04 |
| Published | 2025-02-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | B Braun Medical |
| Distribution | US |
Product
Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal space and epidural space for pain control. Model/Catalog Number: 530159
Reason
Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter. The incorrect catheter connector is smaller than the required catheter connector and therefore is unable to be used to administer medication.
Identifiers
| code_info | UDI-DI 04046964669286 (Primary); 04046964669279 (Unit of Use); Lot Number 0061916572 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1021-2025%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.