FDA recall Z-1021-2025

B. Braun Medical, Inc. · Class II · device

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

Status: Ongoing
Initiation date: 2024-12-04
Report date: 2025-02-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Allentown, PA, United States

Primary source

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