Medical Components, Inc dba MedComp Recall 87265
Description: Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.
Medical Components, Inc dba MedComp Recall 87265 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1184-2021 |
| Event ID | 87265 |
| Event Description | Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system. |
| Product Type | Devices |
| 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 |
| Quantity | 96 pieces total (updated 3/11/2021 additional 72 pieces) |
| Recall 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. |
| Device Classification | 20210317 |
| Device Code Info | Catalog Number: MRDP50AXS, Lot Number: MPDX180, UDI Number: 884908149753 (updated 3/11/2021 added lot number: MPCY660) |
| Center Classification Date | 20210308 |
| Recall Initiation Date | 20210113 |
| Recalling Firm | Medical Components, Inc dba MedComp |
| Initial Notification | Letter |
| Similar To |