Z-1029-04

Circle C Dual Lumen Acute Hemodialysis/Apheresis Catheter Surgical Tray, DLC-600TEC, 12 Fr. x 15.2cm...

Name: Z-1029-04 Circle C Dual Lumen Acute Hemodialysis/Apheresis Catheter Surgical Tray, DLC-600TEC, 12 Fr. x 15.2cm...
Creator: Horizon Medical Products Inc
Published: 2004-05-28
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2004-05-28 / Terminated / root cause: packaging

FDA source

Horizon Medical Products Inc began a recall of Circle C Dual Lumen Acute Hemodialysis/Apheresis Catheter Surgical Tray, DLC-600TEC, 12 Fr. x 15.2cm, Sterile, Manufactured by: Horizon Medical Products, Inc... on 2004-05-28. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1029-04
Status: Terminated
Initiated: 2004-05-28
Posted: 2004-07-20
Terminated: 2005-01-12
Recalling firm: Boston Scientific Corporation
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.
Product code: KOC Accessories, Blood Circuit, Hemodialysis
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.
Root cause tag: packaging
FDA 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.
Product codes and lots: Catalog #DLC600-64C, Lot Numbers 335418 and 356778

Product code KOC

K941851Class IIDual Lumen Catheter (Dlc) TrayNeostar Medical Technologies, Inc. / cleared 1995-03-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)