FDA Device recall Z-1184-2021
Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascula…
- FDA Device
- Class II
- ongoing
- Published 2021-03-17
On 2021-03-17 the FDA classified a Class II recall of Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascula… by Medical Components, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1184-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-01-13 |
| Published | 2021-03-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medical Components |
| Distribution | US |
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.
Identifiers
| code_info | Catalog Number: MRDP50AXS, Lot Number: MPDX180, UDI Number: 884908149753 (updated 3/11/2021 added lot number: MPCY660) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1184-2021%22
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