Horizon Medical Products Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Horizon Medical Products Inc
Lot Codes / Batch Numbers
Catalog #DLC600-64C, Lot Numbers 335418 and 356778
Products Sold
Catalog #DLC600-64C, Lot Numbers 335418 and 356778
Horizon Medical Products Inc is recalling Circle C Dual Lumen Acute Hemodialysis/Apheresis Catheter Surgical Tray, DLC-600TEC, 12 Fr. x 15.2cm due to 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.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consignees were notified via letter on 5/28/2004.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, CA, CO, FL, GA, IL, NJ, NY, OH, PA, SC, TN, TX, VA
Page updated: Jan 10, 2026