Z-0867-04

Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, with PolyFlow Polyurethane Catheter...

Name: Z-0867-04 Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, with PolyFlow Polyurethane Catheter...
Creator: Deltec, Inc
Published: 2004-03-29
License: https://open.fda.gov/license/

Abbott Medical / initiated 2004-03-29 / Terminated / root cause: packaging

FDA source

Deltec, Inc began a recall of Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 Fr Introducer Set, REF... on 2004-03-29. The reason FDA records is "Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization". 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-0867-04
Status: Terminated
Initiated: 2004-03-29
Posted: 2004-07-20
Terminated: 2006-12-28
Recalling firm: Abbott Medical
Product: Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 Fr Introducer Set, REF 21-4071-24
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
Root cause tag: packaging
FDA root cause: Other
Action: A recall letter dated March 26, 2004 gave customers the option of returning the products or using the products if the customer's procedures do not require sterility of the outer surface of the inner tray.
Distribution: The recalled products were shipped nationwide in the United States and worldwide.
Product codes and lots: Lots M26963, M27058, and M27120

Product code LJT

K962695Class IIPort-a-Cath II Venous Implantable Access Systems Preconnected with Polyurethane CatheterSims Deltec, Inc. / cleared 1996-10-01

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)