Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Part Number: CDC-12123-P1A
FDA Recall #Z-1328-2018 — Class II — December 22, 2017
Product Description
Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Part Number: CDC-12123-P1A
Reason for Recall
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Recalling Firm
Arrow International Inc — Reading, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Distribution
Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.
Code Information
Lot Number: 13F17F0081
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated