Recall Z-1021-2025 ยท OFT Spinal Epidural Anesthesia Kit
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
| Date | Jan 24, 2025 (initiated Dec 4, 2024) |
| Status | Open, Classified |
| 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 |
| Quantity | 1090 units |
| Distribution | US Nationwide distribution in the states of MO, OK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.