Device product
Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 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. Product Code: 332079
Z-1149-2024
Product summary
- Event
- Event 93889
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3,480 units
- Official record key
device-enforcement:Z-1149-2024
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: 04046964177224 Lot Number: 0061855319 Exp. Date: 30.APR.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.