Z-0341-06

Silicone Central Venous Catheter with PASV Valve and Polyester Cuff - 6.6F. Boston Scientific Cat. #CVC661IK...

Name: Z-0341-06 Silicone Central Venous Catheter with PASV Valve and Polyester Cuff - 6.6F. Boston Scientific Cat. #CVC661IK...
Creator: Boston Scientific Corporation
Published: 2005-10-28
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-10-28 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Corporation began a recall of Silicone Central Venous Catheter with PASV Valve and Polyester Cuff - 6.6F. Boston Scientific Cat. #CVC661IK M001CVC661IK0. Firm on label: Boston Scientific... on 2005-10-28. The reason FDA records is "Device kits contain B. Braun Locking Tearaway Introducer Systems labeled as 7Fr but may contain 8 Fr sheaths". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0341-06
Status: Terminated
Initiated: 2005-10-28
Posted: 2006-01-06
Terminated: 2007-02-15
Recalling firm: Boston Scientific Corporation
Product: Silicone Central Venous Catheter with PASV Valve and Polyester Cuff - 6.6F. Boston Scientific Cat. #CVC661IK M001CVC661IK0. Firm on label: Boston Scientific Corporation, NAMIC Technology Center, Glens Falls, NY 12801.
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: Device kits contain B. Braun Locking Tearaway Introducer Systems labeled as 7Fr but may contain 8 Fr sheaths.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Boston Scientific letter dated 10/28/2005 sent via Federal Express. Customers (hospitals) instructed to remove and return product.
Quantity in commerce: 434 units
Distribution: DOMESTIC: Nationwide distribution. FOREIGN: Spain, France, Italy, Great Britain, Sweden, Jordan
Product codes and lots: 1009520, 1009824, 1011813, 1013925, 1018980, 1021339, 1022517, 1022952

Product code LJS

K962300Class IIClampless Valved CatheterBmw Medical, Inc. / cleared 1996-09-05

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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)