Z-1184-2021Class II

Power Injectable CT Port insertion kits -

Name: Z-1184-2021 Power Injectable CT Port insertion kits -
Creator: Medical Components, Inc dba MedComp
Published: 2021-01-13
License: https://open.fda.gov/license/

Medical Components, Inc. / initiated 2021-01-13 / Open, Classified / root cause: manufacturing process

FDA source

Medical Components, Inc dba MedComp began a recall of Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system on 2021-01-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1184-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-01-13
Posted: 2021-03-08
Recalling firm: Medical Components, Inc.
Product: Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On 1/13/2021 and 02/10/2021, Medical Components issued an Urgent Medical Device Removal notification to customers via letter notifying customers 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. (updated 3/11/2021)
Quantity in commerce: 96 pieces total (updated 3/11/2021 additional 72 pieces)
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
Product codes and lots: Catalog Number: MRDP50AXS, Lot Number: MPDX180, UDI Number: 884908149753 (updated 3/11/2021 added lot number: MPCY660)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1184-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1184-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-08

Product code LJT

K132177Class IIMedcomp Gen III Power Injectable PortMedcomp ( Medical Components) / cleared 2013-12-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)