Z-1150-2024 Class II Ongoing
FDA device recall Z-1150-2024 was initiated by B. Braun Medical, Inc. on Jan 22, 2024 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 3,890 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 28, 2024
- Initiation Date
- Jan 22, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,890 units
Product 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
Reason for Recall
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.
Distribution Pattern
US Nationwide
Code Information
UDI: 04046964178689 Lot Number: 0061855122 Exp. Date: 25.OCT.2024
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1150-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026