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U.S. Department of Health and Human Services

Class 2 Device Recall CheckFlo Performer Introducer

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  Class 2 Device Recall CheckFlo Performer Introducer see related information
Date Initiated by Firm December 21, 2018
Create Date February 20, 2019
Recall Status1 Terminated 3 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 2
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.
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