FDA Medical Device Recalls (openFDA)
Smiths Medical MD, Inc.: 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
- Recall number
- Z-0442-05
- Recalling firm
- Smiths Medical MD, Inc.
- 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
- Status
- Terminated
- Initiated
- 2004-11-11
- Posted
- 2005-01-28
- Terminated
- 2005-11-14
- Reason
- The catheter became disconnected from the port while implanted in the patient.
- 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
- 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).
- Lot, serial or model codes
- M36262
- 510(k) numbers
- ["K942024"]
- PMA numbers
- not on file
- Product code
- LJT
- Firm FEI
- 2183502
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28