B. Braun Medical, Inc. Recall 93889
Description: 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 catheter (i.e., may be intended for single- or continuous-administration). It is not intended for intrathecal anesthesia. Product Code: 332248
B. Braun Medical, Inc. Recall 93889 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1150-2024 |
| Event ID | 93889 |
| Event Description | 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 catheter (i.e., may be intended for single- or continuous-administration). It is not intended for intrathecal anesthesia. Product Code: 332248 |
| Product Type | Devices |
| Distribution | US Nationwide |
| Quantity | 3,890 units |
| Recall 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. |
| Device Classification | 20240228 |
| Device Code Info | UDI: 04046964178689 Lot Number: 0061855122 Exp. Date: 25.OCT.2024 |
| Center Classification Date | 20240216 |
| Recall Initiation Date | 20240122 |
| Recalling Firm | B. Braun Medical, Inc. |
| Initial Notification | Letter |
| Similar To |