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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow

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  Class 2 Device Recall Arrow see related information
Date Initiated by Firm September 29, 2006
Date Posted December 19, 2006
Recall Status1 Terminated 3 on June 04, 2007
Recall Number Z-0274-2007
Recall Event ID 36522
510(K)Number K911055  K790882  
Product Classification Implantable Vascular Access System - Product Code LJT
Product Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.

Latex-Free A(2) Port , 12 Fr. Introducer Kit.
Ref Product Code: AP-06528
Code Information Product No. AP-06528. Lot Number: 12054, MF3033635, MF3075166, MF3095536, MF3105900, MF3116038, MF4016607, MF4020455, MF4020838, MF4063175, MF4073793, MF4084293, MF4084406, MF4105408, MF5017415, MF5049326, MF6014778, MF6068936, MF6079334.
Recalling Firm/
Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact Paul Cornelison
Manufacturer Reason
for Recall
Catheter has separated from the infusion port body.
FDA Determined
Cause 2
Action The recall notification was sent out to their US customers on 9/29/2006.
Quantity in Commerce 194
Distribution Nationwide. The firm is NOT recalling from international accounts.
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 = LJT and Original Applicant = INTROSTAT
510(K)s with Product Code = LJT and Original Applicant = THEREX CORP.