Device 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
Z-1150-2024
Product summary
- Event
- Event 93889
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3,890 units
- Official record key
device-enforcement:Z-1150-2024
Official wording
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.
Code information: UDI: 04046964178689 Lot Number: 0061855122 Exp. Date: 25.OCT.2024
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
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.