FDAClass IIFebruary 5, 2025

Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended recall

Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal space and epidural space for…

Why was Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal space and epidural space for…
Recalling firm
B. Braun Medical, Inc.
Quantity
1090 units
Distribution
US Nationwide distribution in the states of MO, OK.
Recall date
February 5, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls