Recall Z-1021-2025— B. Braun Medical, Inc.
Class II · Ongoing
Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2024-12-04. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- B. Braun Medical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-12-04
- Firm location
- Allentown, PA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.