Recall Z-1536-2017 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Medical Components, Inc dba MedComp
9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The CT Power Injectable Implantable Infusion Ports are 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 a power injectabl
| Date | Mar 8, 2017 (initiated Feb 23, 2017) |
| Status | Terminated |
| Reason | The 9.6F port kits were packaged with the incorrect valved peelable introducer. The label states the kit contains a 10F valved peelable introducer. The kit is packaged with a 9F valved peelable introducer. The port lumen will not fit through the introducer during the insertion procedure. |
| Root cause | Unknown/Undetermined by firm |
| Action | Medcomp mailed a Customer Notification letter dated February 23, 2017, to all affected customers to inform them of the issue. Customers were asked to examine their inventory and return all unused product. Distributors were also asked to locate the end user/facility of where the affected product was sold and communicate the recall to them. Customers were instructed to contact their customer service representative for a Returned Goods Authorization (RGA) number if necessary at 215-256-4201. Customers were also instructed to complete and return page 2 of the letter by fax to 215-256-9191. For |
| Quantity | 71 units |
| Distribution | Worldwide Distribution to PR and Panama |
| 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 |