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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow Pressure Injectable PICC

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  Class 2 Device Recall Arrow Pressure Injectable PICC see related information
Date Initiated by Firm December 13, 2018
Create Date May 16, 2019
Recall Status1 Terminated 3 on October 01, 2020
Recall Number Z-1365-2019
Recall Event ID 82506
510(K)Number K153487  
Product Classification Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
Product Arrow PICC powered by Arrow VPS Precision Stylet
Product Code:CDC-45052-VPS2

Product Usage:
The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the pressure injectable PICC may not exceed 300 psi.
Code Information Lot /Batch Number: 23F18F0005, 23F18B0583 GTN:40801902120753 
Recalling Firm/
Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact SAME
Manufacturer Reason
for Recall
Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing a 50 cm PICC may contain a 40 cm PICC
FDA Determined
Cause 2
Employee error
Action Arrow International initiated recall notification letter on 13th December 2018 via FedEx 2-day mail describing problem ,health risk and action to take:, immediately discontinue use and quarantine the products. Complete the enclosed Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products.
Quantity in Commerce 963 units (US) in total
Distribution US Nationwide Distribution
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 = LJS and Original Applicant = ARROW INTERNATIONAL, INC. (Subsidiary of Teleflex Inc.)