FDA Medical Device Recalls (openFDA)
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 number
- Z-1029-04
- Recalling firm
- Horizon Medical Products Inc
- 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.
- Status
- Terminated
- Initiated
- 2004-05-28
- Posted
- 2004-07-20
- Terminated
- 2005-01-12
- 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.
- Quantity
- not on file
- Distribution
- AL, CA, CO, FL, GA, IL, NJ, NY, OH, PA, SC, TN, TX & VA.
- Lot, serial or model codes
- Catalog #DLC600-64C, Lot Numbers 335418 and 356778
- 510(k) numbers
- ["K941851"]
- PMA numbers
- not on file
- Product code
- KOC
- Firm FEI
- 3017892510
- Firm city
- Manchester
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28