Recall Z-1030-04 ยท KOC Accessories, Blood Circuit, Hemodialysis
Horizon Medical Products Inc
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 tr
| Date | Jul 20, 2004 (initiated May 28, 2004) |
| Status | Terminated |
| 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. |
| Root cause | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.