Recall Z-1074-2018 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Smiths Medical ASD Inc.
Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); b. VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); c. VEN LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED (1/EA); d. DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO (1/EA); e. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO (1/EA); f. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO, VALVED (1/EA); g. DL, L
| Date | Mar 15, 2018 (initiated Dec 4, 2017) |
| Status | Terminated |
| Reason | Certain models and lots of PORT A CATH implantable port kits may have been misassembled. The kits may incorrectly contain a 6Fr or 6.5Fr size introducer instead of the correct 8.5Fr size introducer. The Power PORT A CATH II kit may also contain the incorrect locking collars in addition to the incorrect sized introducer. |
| Root cause | Process design |
| Action | Customers were notified via letter on about 12/04/2017. Instructions include to examine current inventory for affected product, collect and isolate any potentially affected product, determine the total number of potentially affected product in possession and complete and return the Urgent Medical Device Recall Response Form, return any affected product on hand, and notify customers if the affected products were further distributed. |
| Quantity | 1,077 units total |
| Distribution | Worldwide Distribution. US nationwide including Puerto Rico, Austria, Bahamas, Belgium, Dominican Republic, Netherlands, Spain, and Turks and Caicos. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093414 | PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS Smiths Medical Asd, Inc., Mar 1, 2010 |