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Recall Observatory FDA recall evidence

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

January 22, 2024

Class II

Product summary

Firm
B. Braun Medical, Inc.
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

    reason.no_named_rule · v1.0.0

    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.