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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm September 20, 2004
Date Posted November 24, 2004
Recall Status1 Terminated 3 on March 01, 2005
Recall Number Z-0256-05
Recall Event ID 30048
510(K)Number K953529  
Product Classification Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
Product LifePort¿, Dual Lumen Profile Plastic Dual Port with Poly Urethane Catheter Kit, Product Code/REF: LPS 7255, Manufactured by: Horizon Medical Products, Inc., One Horizon Way, P.O. Box 627, Manchester, GA 31816.The devices are placed in a molded PVC tray. The tray is sealed with a Tyvek lid. The inner sealed tray is then placed in another tray, the Instruments for Use (IFU), Patient Information Booklet (PIB), patient ID card and its label, the IFU for the locking mechanism and the labeling describing the materials and priming volume, are all placed on top of that lid before sealing the outer tray with another Tyvek lid. The product label is applied to the outer tray lid and the entire package-tray inside a tray ¿ is then sterilized. The primary sterile barrier is the inner sealed tray.
Code Information Catalog #LPS 7255, Lot #20474
Recalling Firm/
Horizon Medical Products Inc
1 Horizon Way
Manchester GA 31816-1749
For Additional Information Contact Mary Gossard, M.S
Manufacturer Reason
for Recall
The product has an incorrectly sized introducer included in the kit. The kit contains a 12 French introducer instead of a 7 French introducer.
FDA Determined
Cause 2
Action Consignees were notified by letter on 09/20/2004.
Quantity in Commerce 44 kits
Distribution FL, GA, LA, MD, NJ, OK, TX, VA
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 = STRATO/INFUSAID, INC.