Recall Z-2499-2020 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Smiths Medical ASD Inc.
PORT-A-CATH II POWER P.A.C. Low Profile" system.
| Date | Jun 11, 2020 |
| Status | Terminated |
| Reason | Smiths Medical became aware that one (1) lot of PORT-A-CATH II POWER P.A.C. Low Profile" System (SKU 21-4477-24) was packaged with an 8Fr catheter instead of a 6Fr catheter. |
| Root cause | Under Investigation by firm |
| Action | Smiths Medical became aware that one (1) lot of PORT-A-CATH II POWER P.A.C. Low Profile" System (SKU 21-4477-24) was packaged with an 8Fr catheter. |
| Quantity | 46 kits |
| Distribution | Domestic Distribution: AR, CT, MS,TN,TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072657 | POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS Smiths Medical MD, Inc., Dec 14, 2007 |