Recall Z-0533-2018 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Medical Components, Inc dba MedComp
6.6F Plastic Dignity Low Profile CT Port W/Attachable ChronoFlex Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 Product Usage: Indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with
| Date | May 25, 2017 |
| Status | Terminated |
| Reason | The kit was packaged with the incorrect introducer needle size. The label indicates the kit contains an 18G Needle w/Echo Tip. The kits were packaged with a 21G Needle w/Echo Tip. |
| Root cause | Mixed-up of materials/components |
| Action | On May 25, 2017, Medcomp distributed Product Recall notices to their customers via email. Medcomp requested the return of all un-used affected product. Customers were advised to immediately examine inventory and to quarantine product subject to recall. If product was further distributed, notification of the recall to those individuals is required. Contact your customer service representative for a Returned Goods Authorization (RGA) number if necessary. The request can be made by telephone by calling 215-256-4201. |
| Quantity | 65 units |
| Distribution | Arabia, Australia, Israel, Brunei & Jamaica |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132177 | MEDCOMP GEN III POWER INJECTABLE PORT Medcomp ( Medical Components), Dec 12, 2013 |