Z-0533-2018Class II

6.6F Plastic Dignity Low Profile CT Port W/Attachable ChronoFlex Polyurethane Catheter, Catalog # MRCTI66041...

Name: Z-0533-2018 6.6F Plastic Dignity Low Profile CT Port W/Attachable ChronoFlex Polyurethane Catheter, Catalog # MRCTI66041...
Creator: Medical Components, Inc dba MedComp
Published: 2017-05-25
License: https://open.fda.gov/license/

Medical Components, Inc. / initiated 2017-05-25 / Terminated / root cause: labeling and UDI

FDA source

Medical Components, Inc dba MedComp began a recall of 6.6F Plastic Dignity Low Profile CT Port W/Attachable ChronoFlex Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 Product Usage: Indicated for... on 2017-05-25. FDA classified it as Class II and gives the reason as "The kit was packaged with the incorrect introducer needle size. The label indicates the kit contains an 18G Needle w/Echo Tip. The kits were packaged with a 21G Needle w/Echo Tip". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0533-2018
Classification: Class II
Status: Terminated
Initiated: 2017-05-25
Posted: 2018-02-06
Terminated: 2018-09-04
Recalling firm: Medical Components, Inc.
Product: 6.6F Plastic Dignity Low Profile CT Port W/Attachable ChronoFlex Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 Product Usage: Indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a power injectable needle, the Power Injectable Implantable Infusion Port device is indicated for power injection of contrast media.
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: The kit was packaged with the incorrect introducer needle size. The label indicates the kit contains an 18G Needle w/Echo Tip. The kits were packaged with a 21G Needle w/Echo Tip.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: On May 25, 2017, Medcomp distributed Product Recall notices to their customers via email. Medcomp requested the return of all un-used affected product. Customers were advised to immediately examine inventory and to quarantine product subject to recall. If product was further distributed, notification of the recall to those individuals is required. Contact your customer service representative for a Returned Goods Authorization (RGA) number if necessary. The request can be made by telephone by calling 215-256-4201.
Quantity in commerce: 65 units
Distribution: Arabia, Australia, Israel, Brunei & Jamaica
Product codes and lots: Lot # MHGB030 Exp. Date 2020-07-30

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0533-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0533-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-06

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)