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U.S. Department of Health and Human Services

Class 2 Device Recall MultiLumen Hemodialysis Catheterization Kit

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  Class 2 Device Recall MultiLumen Hemodialysis Catheterization Kit see related information
Date Initiated by Firm December 22, 2017
Create Date April 10, 2018
Recall Status1 Terminated 3 on May 27, 2020
Recall Number Z-1328-2018
Recall Event ID 79512
510(K)Number K143102  
Product Classification Catheter, hemodialysis, triple lumen, non-implanted - Product Code NIE
Product Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Part Number: CDC-12123-P1A
Code Information Lot Number: 13F17F0081
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact Elizabeth Norwood
919-433-4871
Manufacturer Reason
for Recall		 Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
FDA Determined
Cause 2		 Process control
Action The notification letter includes the following instructions for CUSTOMERS: 1. Discontinue use and quarantine any affected products. 2. Complete and return the Recall Acknowledgement Form to start return process. 3. Complete the Recall Acknowledgment Form if there is no product on hand. Instructions for DISTRIBUTORS: 1.Discontinue distribution and quarantine any affected products. 2. Communicate this recall to any customers with affected product. 3. Have the customers return any affected product to you with a completed Recall Acknowledgement Form. 4. Return affected products from inventory using the Recall Acknowledgement Form. 5. Once you have returned recalled products from your own inventory, and collected the recalled products from your customers, please check the box on the enclosed Recall Acknowledgment Form that indicates that you have completed the recall and return the form.
Distribution Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.
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.
510(K) Database 510(K)s with Product Code = NIE and Original Applicant = Arrow International, Inc. (Subsidiary of Teleflex Inc.)
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