Deltec branded PORT-A-CATH II Single-Lumen Low Profile… recallZ-0442-05 · Smiths Medical MD, Inc. · initiated Nov 11, 2004
Terminated All recalls posted in January 2005
Is my device affected?
- 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.
- If yours is listed, follow the instructions from Smiths Medical MD, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- 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
The catheter became disconnected from the port while implanted in the patient.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0442-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 11, 2004
- Posted by the FDA
- Jan 28, 2005
- Recalling firm
- Smiths Medical MD, Inc.
- Quantity
- 75 trays
- Product code
- LJT
- FDA submissions
- K942024
- 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 description
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
Code information (models, lots, serial numbers)
M36262
Other devices under the same FDA submission
2 devices cleared under K942024 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Deltec 21-4083-24Icu Medical, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR28 reports
- Deltec 21-4071-24Icu Medical, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR6 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page