Z-0442-05

Deltec branded PORT-A-CATH II Single-Lumen Low Profile Polysulfone/Titanium Venous Access System...

Name: Z-0442-05 Deltec branded PORT-A-CATH II Single-Lumen Low Profile Polysulfone/Titanium Venous Access System...
Creator: Smiths Medical MD, Inc.
Published: 2004-11-11
License: https://open.fda.gov/license/

Abbott Medical / initiated 2004-11-11 / Terminated

FDA source

Smiths Medical MD, Inc. began a recall of Deltec branded PORT-A-CATH II Single-Lumen Low Profile Polysulfone/Titanium Venous Access System, Pre-assembled with PolyFlow, Ployurethane Catheter, 2.6 mm... on 2004-11-11. The reason FDA records is "The catheter became disconnected from the port while implanted in the patient". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0442-05
Status: Terminated
Initiated: 2004-11-11
Posted: 2005-01-28
Terminated: 2005-11-14
Recalling firm: Abbott Medical
Product: Deltec branded PORT-A-CATH II Single-Lumen Low Profile Polysulfone/Titanium Venous Access System, Pre-assembled with PolyFlow, Ployurethane Catheter, 2.6 mm (7.8 Fr) O.D. x 1.6 mm I.D., 8.5 Fr Introducer Set. Immediate package states Contents of unopened and undamaged individual product packages are STERILE and non-pyrogenic. Check package integrity before use. Destroy after use. Do not resterilize. Latex free. Deltec, Inc. 1265 Grey Fox Road, St. Paul, MN 55112
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: The catheter became disconnected from the port while implanted in the patient.
FDA root cause: Other
Action: USA consignees were contacted by telephone on 11/11/04. The international consignees were e-mailed and telephone contacted on 11/11/04. The Customer Recall Notification Letter was mailed or faxed on 11/16/04. Customers were asked to inspect their inventory for the affected recall lot and then requested to return any unused product to Smiths Medical. As a result of the recall, some customers may be affected by product unavailability. Smiths'' is endeavoring to have product available as soon as possible. For implanted product it is essential to confirm portal and catheter integrity as described in the Instructions for Use supplied with the product before any injection or infusion therapy.
Quantity in commerce: 75 trays
Distribution: To 11 facilities in FL, GA, ME, MN, NH, NJ, OK, TX, WI, WV and Peurto Rico. And to 2 international distributors (Canada and Taiwan).
Product codes and lots: M36262

Product code LJT

K942024Class IIPort-a-Cath Low Profile Implantable Venous Access SystemPharmacia Deltec, Inc. / cleared 1994-07-26

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)