Deltec branded PORT-A-CATH II Single-Lumen Low Profile Polysulfone/Titanium Venous Access System, Pre-assembled with Pol
FDA device recall Z-0442-05 · posted 2005-01-28 · Terminated
Recall details
- Recalling firm
- Smiths Medical MD, Inc.
- Reason for recall
- The catheter became disconnected from the port while implanted in the patient.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LJT
- Quantity affected
- 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).
- Date initiated
- 2004-11-11
- Date posted
- 2005-01-28
- Date terminated
- 2005-11-14
- Location
- Saint Paul, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM (K942024) | Pharmacia Deltec, Inc. | 1994-07-26 |