Recall Z-1150-2024 ยท OGE Epidural Anesthesia Kit
B. Braun Medical, Inc.
Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock LOR Tray (Kit) A collection of devices intended for the administration of an analgesic or anesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anesthetic agent and a needle, with additional devices utilized for the procedure (e.g., syringe, dressings), and may include a ca
| Date | Feb 16, 2024 (initiated Jan 22, 2024) |
| Status | Open, Classified |
| Reason | Kits should contain Filter Straws with Standard Luer Connections however, the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit. |
| Root cause | Process control |
| Action | B.Braun issued Urgent Medical Device Recall letter on Monday, January 22, 2024. Letter states reason for recall, health risk and action to take: 1. Review the Device Recall Notification and ensure that all users of the product in your organization, and other concerned personnel are informed about this recall. If you are a distributor and have further distributed the product, please forward this notice to your consignees. The recall is to be extended to the user level. 2. Determine your current inventory of the affected batches within inventory of your facility, cease use and quarantine product |
| Quantity | 3,890 units |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.