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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.
Brand
Medical Components, Inc dba MedComp
Lot Codes / Batch Numbers
Catalog Number: MRDP50AXS, Lot Number: MPDX180, UDI Number: 884908149753 (updated 3/11/2021 added lot number: MPCY660)
Products Sold
Catalog Number: MRDP50AXS, Lot Number: MPDX180, UDI Number: 884908149753 (updated 3/11/2021 added lot number: MPCY660)
Medical Components, Inc dba MedComp is recalling Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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)
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026