Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for… — Class II medical device recall Z-1021-2025
Ongoing recall by B. Braun Medical, Inc., reported 2025-02-05, distributed nationwide. Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidu
| Recall number | Z-1021-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | B. Braun Medical, Inc., Allentown, PA, United States |
| Recall initiated | 2024-12-04 |
| Classified | 2025-01-24 |
| Reported by FDA | 2025-02-05 |
| Distributed | Nationwide (US) |
| Quantity | 1,090 units |
| UPC / GTIN / UDI-DI | 04046964669279, 04046964669286 |
| Lot numbers | 0061916572 |
| Model numbers | 530159 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1021-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.