FDA Device recall Z-1150-2024
Epidural tray
- FDA Device
- Class II
- ongoing
- Published 2024-02-28
On 2024-02-28 the FDA classified a Class II recall of Epidural tray by B Braun Medical, citing kits should contain Filter Straws with Standard Luer Connections however, the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1150-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-22 |
| Published | 2024-02-28 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | B Braun Medical |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | UDI: 04046964178689 Lot Number: 0061855122 Exp. Date: 25.OCT.2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1150-2024%22
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