FDA recall Z-1149-2024

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

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

US Nationwide

Key facts

Status

Ongoing

Initiation date

2024-01-22

Report date

2024-02-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Allentown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1149-2024