• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Arrow TwoLumen CVC Kit with Blue Flex Tip Catheter

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall Arrow TwoLumen CVC Kit with Blue Flex Tip Catheter see related information
Date Initiated by Firm July 31, 2013
Date Posted August 14, 2013
Recall Status1 Terminated 3 on April 28, 2015
Recall Number Z-1965-2013
Recall Event ID 65829
510(K)Number K862056  
Product Classification Catheter, percutaneous - Product Code DQY
Product Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.
Code Information Catalog # AK-17702-CDC, lot # RF2083258
Recalling Firm/
Arrow International Inc
2400 Bernville Road
Reading PA 19605
For Additional Information Contact Customer Support
Manufacturer Reason
for Recall
Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen.
FDA Determined
Cause 2
Labeling Change Control
Action An "Urgent Medical Device Recall Notification" letter dated July 31, 2013 was sent to direct accounts requesting immediate discontinuation of use and quarantine of all affected product on hand. Negative responses were also requested and the immediate return of product to Arrow was authorized. Questions were directed to Customer Service at 800 343-2935.
Quantity in Commerce 156
Distribution AL, PA, CT, NC, VA, KS, RI, AZ, NJ, and IL.
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 = DQY and Original Applicant = ARROW INTL., INC.