FDA-Device2025-02-05Class II
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.
Hazard
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.
Sold states
US Nationwide distribution in the states of MO, OK.
Affected count
1090 units
Manufactured in
901 Marcon Blvd, Allentown, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1021-2025Don't want to check this manually?
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