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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