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U.S. Department of Health and Human Services

Class 2 Device Recall VitalPort Vascular Access System

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  Class 2 Device Recall VitalPort Vascular Access System see related information
Date Initiated by Firm November 28, 2017
Create Date March 27, 2018
Recall Status1 Terminated 3 on October 03, 2018
Recall Number Z-1223-2018
Recall Event ID 79425
510(K)Number K081425  
Product Classification Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
Product Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S,

Product usage: The devices are intended for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling.
Code Information IPI, P-S
Recalling Firm/
Cook Vascular Inc.
1186 Montgomery Ln
Vandergrift PA 15690-6065
For Additional Information Contact Cook Medical Customer Relations Department
Manufacturer Reason
for Recall
Non-coring needle provided with the Cook Vital-Port¿ Vascular Assess System (Vital-Port) may cut or dislodge a core or sliver of material from the Vital-Port septum when the non-coring needle is inserted into the Vital-Port. This needle is used on the initial implant of the Vital-Port. Vital-Port products that have been successfully placed in patients are not impacted by this recall.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Removal for all non-expired lots of the Cook Vital-Port Vascular Access System. Written recall communication letters will be mailed via courier to US Consignees.plan to STORE recalled product(s)? (if returned) Recalled products will be returned to global regional distribution warehouses to be quarantined in a marked receiving area of returned goods. 8.9 Provide plan for final DISPOSITION for recalled product(s)? All recalled products will be destroyed at the regional distribution warehouses. A certificate of destruction will be provided upon completion of destruction prior to the completion of the recall. Products remaining in the control of Cook will be assessed for rework to replace the non-coring needle.
Quantity in Commerce 31,006 Units
Distribution The devices have been distributed within the United States and the following countries: United Arab Emirates, Argentina, Austria, Australia, Barbados, Belgium, Bulgaria, Bermuda, Brazil, Canada, Switzerland, Colombia, Costa Rica, Cyprus, Czech Republic, Germany, Denmark, Spain, Finland, Faroe Islands, France, United Kingdom, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Iceland, Italy, Jamaica, Jordan, Japan, Kenya, South Korea, Kuwait, Lebanon, Latvia, Morocco, Macedonia, Mexico, Netherlands, New Zealand, Oman, Panama, Poland, Portugal, Serbia, Saudi Arabia, Sweden, San Marino, El Salvador, Turkey, Trinidad & Tobago, Ukraine, Uruguay, Venezuela, Virgin Islands, Kosovo, China, and South Africa.
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 = COOK VASCULAR, INC.