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Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anestheti...

FDA Recall #Z-1021-2025 — Class II — December 4, 2024

Recall #Z-1021-2025 Date: December 4, 2024 Classification: Class II Status: Ongoing

Product Description

Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal space and epidural space for pain control. Model/Catalog Number: 530159

Reason for Recall

Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter. The incorrect catheter connector is smaller than the required catheter connector and therefore is unable to be used to administer medication.

Recalling Firm

B. Braun Medical, Inc. — Allentown, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

1090 units

Distribution

US Nationwide distribution in the states of MO, OK.

Code Information

UDI-DI 04046964669286 (Primary); 04046964669279 (Unit of Use); Lot Number 0061916572

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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