FDAClass IIAugust 25, 2021

NEO-KATH Epidural Catheter Set recall

NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile

Why was NEO-KATH Epidural Catheter Set recalled?

Potential for stylet to protrude from the distal end of the catheter

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

Reference Number 200-2430, Lot Numbers 16308275 (Expiration August 2022), 16308382 (Expiration October 2022)

Product
NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile
Recalling firm
Epimed International
Quantity
132 units
Distribution
Worldwide distribution, with US distribution to CA, DE, OH, OK, PA, VA, WA, WV. International distribution to Canada and Iran.
Recall date
August 25, 2021
Classification
Class II
Status
Completed
Agency
FDA (device)
Open FDA enforcement record Latest recalls