Z-1095-05

ChemoSite Implantable venous access sytem with printed Polyurethane Catheter and 9 French Introducer Kit...

Name: Z-1095-05 ChemoSite Implantable venous access sytem with printed Polyurethane Catheter and 9 French Introducer Kit...
Creator: United States Surgical Corporation
Published: 2005-06-30
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2005-06-30 / Terminated

FDA source

United States Surgical Corporation began a recall of ChemoSite Implantable venous access sytem with printed Polyurethane Catheter and 9 French Introducer Kit Catalog Number: 120045 on 2005-06-30. The reason FDA records is "The tear away introducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1095-05
Status: Terminated
Initiated: 2005-06-30
Posted: 2005-08-06
Terminated: 2010-09-14
Recalling firm: Medtronic, Inc.
Product: ChemoSite Implantable venous access sytem with printed Polyurethane Catheter and 9 French Introducer Kit Catalog Number: 120045
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: The tear away introducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use
FDA root cause: Other
Action: United States Surgical notified customers by letter dated June 30, 2005 requesting return of the recalled product.
Quantity in commerce: 2393 units
Distribution: Nationwide Foreign: Australia, Canada, Germany,Israel, Uruguay, Chile,
Product codes and lots: Lot Numbers: N4G22 N4G215 N4G436 N4J29 N4J212 N4K218 N4L258 N4M213

Product code LJS

K902135Class IIPercutaneous Introducer KitDevice Labs, Inc. / cleared 1990-08-01

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)