Recall Z-1184-2021 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Medical Components, Inc dba MedComp
Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.
| Date | Mar 8, 2021 (initiated Jan 13, 2021) |
| Status | Open, Classified |
| Reason | The 5F Dignity CT Port kits were packaged with the incorrect size port. The kits include a 6.6F port instead of the correct 5F port. The inability to connect the catheter lumen to the port stem because of the incorrect size may not be noted until well into the procedure, after the catheter lumen is placed in the vessel. An alternate port will need to be obtained prolonging the procedure. A prolonged insertion procedure increases any risk associated with a surgical procedure. |
| Root cause | Employee error |
| Action | On 1/13/2021 and 02/10/2021, Medical Components issued an Urgent Medical Device Removal notification to customers via letter notifying customers the 5F Dignity CT Port kits were packaged with the incorrect size port. The kits include a 6.6F port instead of the correct 5F port. (updated 3/11/2021) |
| Quantity | 96 pieces total (updated 3/11/2021 additional 72 pieces) |
| Distribution | US Nationwide distribution in the states of CA, DC, GA, IL, IN, MA, MI, NJ, NM, NY, OH, PA, TX. Updated 3/11/2021 |
| 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 |