PlainRecalls
FDA Devices Moderate 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

Reported: February 28, 2024 Initiated: January 22, 2024 #Z-1149-2024

Product 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 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.

Details

Recalling Firm
B. Braun Medical, Inc.
Units Affected
3,480 units
Distribution
US Nationwide
Location
Allentown, PA

Frequently Asked Questions

What product was recalled?
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. Recalled by B. Braun Medical, Inc.. Units affected: 3,480 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 28, 2024. Severity: Moderate. Recall number: Z-1149-2024.