Reported Mar 17, 2021 · Ongoing
Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated…
Medical Components, Inc. dba MedComp
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medical Components, Inc dba MedComp · 1499 Delp Dr · Harleysville, PA · 19438-2936
Is this the product you have?
- Power Injectable
- CT Port insertion kits - Product Usageis an implantable access device designed to provide repeated access to the vascular system
- Lot codes and dates
- Catalog NumberMRDP50AXS
- Lot NumberMPDX180
- UDI Number884908149753 (updated 3/11/2021
- added lot numberMPCY660)
- Amount recalled
- 96 pieces total (updated 3/11/2021 additional 72 pieces)
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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