RecallRadar

FDA Device recall Z-1149-2024

Epidural tray

On 2024-02-28 the FDA classified a Class II recall of Epidural tray by B Braun Medical, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1149-2024
ClassificationClass II
Statusongoing
Initiated2024-01-22
Published2024-02-28
Last updated2026-09-13 11:57 UTC
CompanyB Braun Medical
DistributionUS

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

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.

Identifiers

code_infoUDI: 04046964177224 Lot Number: 0061855319 Exp. Date: 30.APR.2024

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1149-2024%22

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