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

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.

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 issued Urgent Medical Device Correction Notification letter on 12/04/24 via USPS Certified Mail. Letter states reason for recall, health risk and action to take: 1. Review the Medical Device Correction Notification in its entirety and ensure that all users in your organization of the above-mentioned product, and other concerned persons are informed about this voluntary correction. If you have further distributed the affected product, please forward this notice to your consignees. The correction is to be extended to the hospital/healthcare facility level. 2. Post this notification where the affected products are stored. Additional catheter connectors are being supplied to you and should be stored where the affected inventory is utilized. In the event that an incorrect catheter connector is identified, please utilize these additional devices to facilitate replacement. 3. Returned the completed Urgent Medical Device Correction Acknowledgement Form to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or email to recalls@bbraunusa.com within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). Adverse reactions or quality problems experienced with this product, or questions about this recall may be reported to BBMI s Postmarket Surveillance Department by calling 1-844-903-6417.

• FDA enforcement recordOfficial FDA database entry for Z-1021-2025
• FDA device classification · OFTOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5120The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find B. Braun Medical, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.