FDA Recall
Terminated
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: Z-1029-04
·
Initiated May 28, 2004
Recall
- Recall Number
- Z-1029-04
- Event Number
- 29253
- Firm
- Horizon Medical Products Inc
- FEI Number
- 3017892510
- Product Code
- KOC
- Status
- Terminated
- Root Cause
- Other
- Initiated
- May 28, 2004
- Posted
- July 20, 2004
- Terminated
- January 12, 2005
- Address
- 1 Horizon Way, Manchester, GA, 31816-1749
Description
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.
Reason
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.
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.