Recall Z-1626-2012 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Medical Components, Inc dba MedComp
8F Plastic Dignity Mid-Sized CT Port w/Silicone Filled Suture Holes and w/Attachable ChronoFlex Polyurethane Catheter. Catalog # MRCTI8000S. The Power Injectable, Implantable Infusion Port is an implantable single fluid reservoir port with a polyurethane (8F) catheter attachable for application by the inserting physician.
| Date | May 18, 2012 (initiated Apr 12, 2012) |
| Status | Terminated |
| Reason | 50 trays of Dignity Low Profile CT Port were labeled as Dignity Mid-Sized CT Port. |
| Root cause | Employee error |
| Action | On April 12, 2012, MedComp sales representatives and the foreign distributor were notified via e-mail with a "Product Alert" notification. The issue was described and requested actions were provided to recipients. |
| Quantity | 50 trays |
| Distribution | Worldwide Distribution - - USA, including the states of CA, NJ, AZ, PA, TN and the country of Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070003 | POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED) Medcomp, May 15, 2007 |