Epimed International: Medical Device Recall in 2021 - (Recall #: Z-2313-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile

Product Classification:

Class II

Date Initiated: December 28, 2017

Date Posted: August 25, 2021

Recall Number: Z-2313-2021

Event ID: 88317

Reason for Recall:

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

Status: Completed

Product Quantity: 140 units

Code Information:

Reference Number 201-2430, Lot Numbers 16308139 (Expiration August 2022), 16308383 (Expiration October 2022)

Distribution Pattern:

Worldwide distribution, with US distribution to CA, DE, OH, OK, PA, VA, WA, WV. International distribution to Canada and Iran.

Voluntary or Mandated:

Voluntary: Firm initiated