Class II

Medical Device Recall: 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

B. Braun Medical, Inc. · December 4, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

1090 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1021-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

B. Braun Medical, Inc. Medical Device Recall: 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 | SafeCheck