Recall Z-2313-2021— Epimed International

Name: FDA recall Z-2313-2021
Creator: U.S. Food and Drug Administration
Published: 2017-12-28

Class II · Completed

Class II FDA medical device recall by Epimed International, initiated 2017-12-28. It names one FDA 510(k) clearance: K981329. Product: NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile. Reason: Potential for stylet to protrude from the distal end of the catheter.

Recalling firm: Epimed International
Classification: Class II
Status: Completed
Initiated: 2017-12-28
Firm location: Farmers Branch, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K981329 — FETH-R-KATHEpimed International, Inc.·cleared 1998-08-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.