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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-0273-2007
Recall Event ID 36522
510(K)Number K950212  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, 10 Fr. Introducer Kit
Ref Product No. AP-06530
Code Information Product No: AP-06530. Lot Numbers: 11750, 11999, 12059, MF4031397, MF4042081, MF4062934, MF4063103, MF4073794, MF5027702, MF5059738, MF5060177, MF5060656, MF5081903, MF5103211, MF6036473, MF6036909, MF6068938, MS3100148.
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact Paul Cornelison
610-378-0131
Manufacturer Reason
for Recall		 Catheter has separated from the infusion port body.
FDA Determined
Cause 2		 Other
Action The recall notification was sent out to their US customers on 9/29/2006.
Quantity in Commerce 210
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.
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