Medical Components, Inc dba MedComp recalls Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated a…

Recall date

January 13, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1184-2021

FDA classification

Class II

Brand / firm

Medical Components, Inc dba MedComp

Sold / distributed

US Nationwide distribution in the states of CA, DC, GA, IL, IN, MA, MI, NJ, NM, NY, OH, PA, TX. Updated 3/11/2021

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.