# FDA recall Z-1021-2025

> **B. Braun Medical, Inc.** · Class II · device recall initiated 2024-12-04.

## 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.

## Distribution

US Nationwide distribution in the states of MO, OK.

## Key facts

- **Recall number:** Z-1021-2025
- **Recalling firm:** B. Braun Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-04
- **Report date:** 2025-02-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Allentown, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1021-2025

## Citation

> AI Analytics. FDA recall Z-1021-2025. Retrieved 2026-08-23 from https://api.ai-analytics.org/recall/Z-1021-2025. Source: US FDA. Licensed CC0.

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