Z-2190-2008

Vital Port Vascular Access System Polysulfone Petite with detached 0.9mm catheter

Name: Z-2190-2008 Vital Port Vascular Access System Polysulfone Petite with detached 0.9mm catheter
Creator: Cook Vascular Inc.
Published: 2008-04-24
License: https://open.fda.gov/license/

Cook Vandergrift, Inc. / initiated 2008-04-24 / Terminated / root cause: packaging

FDA source

Cook Vascular Inc. began a recall of Vital Port Vascular Access System Polysulfone Petite with detached 0.9mm catheter on 2008-04-24. The reason FDA records is "Mislabeled - wrong size catheter was packaged in the box". 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-2190-2008
Status: Terminated
Initiated: 2008-04-24
Posted: 2008-09-17
Terminated: 2008-09-18
Recalling firm: Cook Vandergrift, Inc.
Product: Vital Port Vascular Access System Polysulfone Petite with detached 0.9mm catheter
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: Mislabeled - wrong size catheter was packaged in the box
Root cause tag: packaging
FDA root cause: Packaging process control
Action: The recalling firm issued an Urgent Product Recall letter dated 4/30/08 to inform their customers of the problem and the need to return the product. The letter also instructed the customers to notify sub accounts. Contact Cook Vascular at 1-724-845-8621 for assistance.
Quantity in commerce: 21 units
Distribution: The products were shipped to distributors in Japan and Brazil.
Product codes and lots: Catalog number IP-S5118-N. Lot number N73127

Product code LJT

K924748Class IIVital-Port Vasc Access 901Op/911op/9012p/9112pMed Institute, Inc. / cleared 1993-07-28

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)