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Class 2 Device Recall Circle C |
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Date Initiated by Firm |
May 28, 2004 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on January 12, 2005 |
Recall Number |
Z-1030-04 |
Recall Event ID |
29253 |
Product Classification |
Accessories, Blood Circuit, Hemodialysis - Product Code KOC
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Product |
Circle C¿ Dual Lumen Acute Hemodialysis/Apheresis Catheter Surgical Tray, DLC-600TEC, DCL-800TEC 12 Fr. x 20.3cm, 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 # DLC800-TEC, Lot Numbers 3538781, 356779 & 342251. |
Recalling Firm/ Manufacturer |
Horizon Medical Products Inc 1 Horizon Way Manchester GA 31816-1749
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For Additional Information Contact |
Mary Gossard, M.S. 800-782-9330 Ext. 3023
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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.
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FDA Determined Cause 2 |
Other |
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
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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.
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