NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
FDA Recall #Z-2313-2021 — Class II — December 28, 2017
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
Recalling Firm
Epimed International — Farmers Branch, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
140 units
Distribution
Worldwide distribution, with US distribution to CA, DE, OH, OK, PA, VA, WA, WV. International distribution to Canada and Iran.
Code Information
Reference Number 201-2430, Lot Numbers 16308139 (Expiration August 2022), 16308383 (Expiration October 2022)
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated