The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2312-2021·Announced 2021-08-25

NEO-KATH Epidural Catheter Set recalled for potential stylet protrusion

Epimed International recalls NEO-KATH Epidural Catheter Set (Lot 16308275, 16308382) due to potential stylet protrusion from the catheter distal end, which poses injury risk during epidural procedures.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall for a potential stylet protrusion defect in an epidural catheter. No illnesses or injuries are reported in the source text. As a risk-of-harm product without reported injury, this warrants a High severity classification per the rubric.

Plain-English summary

Epimed International is recalling the NEO-KATH Epidural Catheter Set, Reference Number 200-2430, Sterile. The recall affects 132 units distributed worldwide. Lot Numbers 16308275 (expiration August 2022) and 16308382 (expiration October 2022) are included in this recall.

There is a potential for the stylet to protrude from the distal end of the catheter. This defect could result in patient injury during epidural injection procedures.

In the United States, affected product was distributed to California, Delaware, Ohio, Oklahoma, Pennsylvania, Virginia, Washington, and West Virginia. International distribution includes Canada and Iran.

Healthcare facilities and practitioners who have affected units should discontinue use and contact Epimed International for replacement or further instructions.

The recalled product

Product
NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile
Manufacturer
Epimed International
Category
Medical Device — Epidural Catheter
Hazard
Affected units
132

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed in 8 states:

Part of a larger recall action

This product is one of 2 recalled by Epimed International under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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