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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow PICC

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  Class 2 Device Recall Arrow PICC see related information
Date Initiated by Firm April 23, 2019
Create Date June 16, 2019
Recall Status1 Terminated 3 on January 13, 2021
Recall Number Z-1819-2019
Recall Event ID 82865
510(K)Number K112896  
Product Classification Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
Product Arrow¿ PICC with Chlorag+ard¿ Technology
Product Code: PR 45541 HPHNL
Code Information Batch Code:13F17A0165, 13F17D0327, 13F18A0208, 13F18B0457, 13F18F0416 
Recalling Firm/
Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact
Manufacturer Reason
for Recall
Lidstock states the incorrect expiration date for the product
FDA Determined
Cause 2
Process control
Action Arrow International initiated recall by letter dated April 23,2019 described the problem, health risk and action to take: If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Complete the enclosed Acknowledgement Form 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. Distributors requested to subrecall. Questions, contact your local sales representative or Customer Service at 1-866-396-2111.
Quantity in Commerce 983 units
Distribution Nationwide Foreign:
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(SUBSIDIARY OF TELEFLEX INC.)