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U.S. Department of Health and Human Services

Class 2 Device Recall Polysulfone Petite Vital Port

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  Class 2 Device Recall Polysulfone Petite Vital Port see related information
Date Initiated by Firm April 24, 2008
Date Posted September 17, 2008
Recall Status1 Terminated 3 on September 18, 2008
Recall Number Z-2191-2008
Recall Event ID 48642
510(K)Number K924748  
Product Classification Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
Product Vital Port Vascular Access System Polysulfone Petite with detached 1.0mm catheter
Code Information Catalog number IP-S6118. Lot number N73153
Recalling Firm/
Manufacturer		 Cook Vascular Inc.
1186 Montgomery Ln
Vandergrift PA 15690-6065
For Additional Information Contact Thomas Kardos
724-845-8621 Ext. 2225
Manufacturer Reason
for Recall		 mislabeled - wrong size catheter was packaged in the box
FDA Determined
Cause 2		 Packaging process control
Action The recalling firm issued an Urgent Product Recall letter dated 4/30/08 to inform their customers of the problem and the need to return the product. The letter also instructed the customers to notify sub accounts. Contact Cook Vascular at 1-724-845-8621 for assistance.
Quantity in Commerce 20 units
Distribution The products were shipped to distributors in Japan and Brazil.
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 = MED INSTITUTE, INC.
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