Class 2 Device Recall CheckFlo Performer Introducer

• Date Initiated by Firm: December 21, 2018
• Create Date: February 20, 2019
• Recall Status: Terminated on April 30, 2020
• Recall Number: Z-0851-2019
• Recall Event ID: 82007
• Product Classification: Introducer, catheter - Product Code DYB
• Product: Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571
• Code Information: lot 8858425
• Recalling Firm/ Manufacturer: Cook Inc.; 750 N Daniels Way; Bloomington IN 47404-9120
• For Additional Information Contact: Cook Medical Customer Relations Department; 812-339-2235
• Manufacturer Reason for Recall: The products were manufactured with longer than specified sheaths.
• FDA Determined Cause: Under Investigation by firm
• Action: Urgent Medical Device Recall letters dated 12/21/18 were sent to customers.
• Quantity in Commerce: 24
• Distribution: The products were distributed to the following US states: CA, CT, GA, MA, NY, PA, VA, and WI.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.