Medical device recalls Moderate risk

B. Braun Medical, Inc. recalls Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal…

Recall date
December 4, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1021-2025
FDA classification
Class II
Brand / firm
B. Braun Medical, Inc.
Sold / distributed
US Nationwide distribution in the states of MO, OK.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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