Z-1067-03

Ventra Percutaneous Intravenous Catheter Repair Kit for 9 French Dual-Lumen External Catheter Segment...

Name: Z-1067-03 Ventra Percutaneous Intravenous Catheter Repair Kit for 9 French Dual-Lumen External Catheter Segment...
Creator: Deltec, Inc
Published: 2003-07-08
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-07-08 / Terminated

FDA source

Deltec, Inc began a recall of Ventra Percutaneous Intravenous Catheter Repair Kit for 9 French Dual-Lumen External Catheter Segment, Reorder Number 21-0106 on 2003-07-08. The reason FDA records is "Silicone adhesive in kits used to repair damaged catheters did not set (cure) properly and remained in a tacky state". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1067-03
Status: Terminated
Initiated: 2003-07-08
Posted: 2003-07-30
Terminated: 2004-07-02
Recalling firm: Abbott Medical
Product: Ventra Percutaneous Intravenous Catheter Repair Kit for 9 French Dual-Lumen External Catheter Segment, Reorder Number 21-0106
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Silicone adhesive in kits used to repair damaged catheters did not set (cure) properly and remained in a tacky state.
FDA root cause: Other
Action: A recall letter, sent to the consignees on July 8, 2003, gave them the option of returning the kits or waiting for the firm to provide them with replacement silicone adhesive.
Distribution: The product was shipped to 14 consignees (hospitals) in California, Illinois, Kansas, Michigan, Minnesota, Missouri, Pennsylvania, and Texas.
Product codes and lots: Lot numbers M20690, 95310

Product code FOZ

K904334Class IIPercutaneous Intravenous Catheter Repair KitPharmacia Deltec, Inc. / cleared 1990-11-05

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)