FDA Medical Device Recalls (openFDA)
B. Braun Medical, Inc.: 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
- Recall number
- Z-1021-2025
- Recalling firm
- B. Braun Medical, Inc.
- 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
- Status
- Open, Classified
- Initiated
- 2024-12-04
- Posted
- 2025-01-24
- Terminated
- not on file
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 1090 units
- Distribution
- US Nationwide distribution in the states of MO, OK.
- Lot, serial or model codes
- UDI-DI 04046964669286 (Primary); 04046964669279 (Unit of Use); Lot Number 0061916572
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OFT
- Firm FEI
- 2523676
- Firm city
- Allentown
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28