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U.S. Department of Health and Human Services

Class 2 Device Recall Circle C

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  Class 2 Device Recall Circle C see related information
Date Initiated by Firm May 28, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on January 12, 2005
Recall Number Z-1029-04
Recall Event ID 29253
510(K)Number K941851  
Product Classification Accessories, Blood Circuit, Hemodialysis - Product Code KOC
Product Circle C¿ Dual Lumen Acute Hemodialysis/Apheresis Catheter Surgical Tray, DLC-600TEC, 12 Fr. x 15.2cm, Sterile, Manufactured by: Horizon Medical Products, Inc., One Horizon Way, P.O. Box 627, Manchester, GA 31816, 1-800-472-5221. The product is a clear rigid plastic surgical tray containing components required for implantation. Components of the inner tray are in a separate sterile pouch. The tray and components are then sealed in an outer clear plastic pouch.
Code Information Catalog #DLC600-64C, Lot Numbers 335418 and 356778
Recalling Firm/
Horizon Medical Products Inc
1 Horizon Way
Manchester GA 31816-1749
For Additional Information Contact Mary Gossard, M.S.
800-782-9330 Ext. 3023
Manufacturer Reason
for Recall
The products have a potential defective seal that closes the product's OUTER POUCH. The surface of the INNER TRAY may no longer be sterile.
FDA Determined
Cause 2
Action Consignees were notified via letter on 5/28/2004.
Distribution AL, CA, CO, FL, GA, IL, NJ, NY, OH, PA, SC, TN, 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 = KOC and Original Applicant = NEOSTAR MEDICAL TECHNOLOGIES, INC.