FDA Enforcement
Class II
Ongoing
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
Recall: Z-1149-2024
·
Reported February 28, 2024
Enforcement
- Recall Number
- Z-1149-2024
- Event ID
- 93889
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- B. Braun Medical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 28, 2024
- Initiation Date
- January 22, 2024
- Classification Date
- February 16, 2024
- Address
- 901 Marcon Blvd, N/A, Allentown, PA, 18109-9512, United States
Description
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
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 Info
UDI: 04046964177224 Lot Number: 0061855319 Exp. Date: 30.APR.2024
Distribution
US Nationwide
Quantity
3,480 units