Skip to content

Port-A-Cath II Low Profile Polysulfone/Titanium Venous… recallZ-0868-04 · Deltec, Inc · initiated Mar 29, 2004

Terminated All recalls posted in July 2004

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Deltec, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-0868-04
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 29, 2004
Posted by the FDA
Jul 20, 2004
Recalling firm
Deltec, Inc
Product code
LJT
FDA submissions
K962695
Distribution
The recalled products were shipped nationwide in the United States and worldwide.

Product description

Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 Fr Introducer Set, REF 21-4073-24

Code information (models, lots, serial numbers)

Lot M27131

Other devices under the same FDA submission

3 devices cleared under K962695 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 28667).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page