Z-1148-06

Auto Suture-ChemoSite Low Profile -implantable low profile Venous Access System with printed polyurethane...

Name: Z-1148-06 Auto Suture-ChemoSite Low Profile -implantable low profile Venous Access System with printed polyurethane...
Creator: United States Surgical
Published: 2006-05-22
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2006-05-22 / Terminated

FDA source

United States Surgical began a recall of Auto Suture-ChemoSite Low Profile -implantable low profile Venous Access System with printed polyurethane catheter and 9 French Introducer Kit Catalog Number... on 2006-05-22. The reason FDA records is "The 9F device may contain a 10 F sheath instead of the 9F". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1148-06
Status: Terminated
Initiated: 2006-05-22
Posted: 2006-06-17
Terminated: 2007-12-12
Recalling firm: Medtronic, Inc.
Product: Auto Suture-ChemoSite Low Profile -implantable low profile Venous Access System with printed polyurethane catheter and 9 French Introducer Kit Catalog Number: 120021
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: The 9F device may contain a 10 F sheath instead of the 9F
FDA root cause: Other
Action: United States Surgical notified accounts by letter dated 5/22/06, requesting return of inventory. Distributors were requested to provide customer list to USS for contacting customers.
Quantity in commerce: 63 UNITS
Distribution: Nationwide and International Australia, Brazil, Panama City, Singapore, Chile, France, Germany, Israel, Argentina, Quebec
Product codes and lots: Lot Numbers: N5M40, N6B01

Product code FOZ

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

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)