Recall Z-1184-2021— Medical Components, Inc dba MedComp
Class II · Ongoing
Class II FDA medical device recall by Medical Components, Inc dba MedComp, initiated 2021-01-13. It names one FDA 510(k) clearance: K132177. Product: Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.. 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..
- Recalling firm
- Medical Components, Inc dba MedComp
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-01-13
- Firm location
- Harleysville, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.