Z-1536-2017Class II

9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The CT Power Injectable Implantable...

Name: Z-1536-2017 9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The CT Power Injectable Implantable...
Creator: Medical Components, Inc dba MedComp
Published: 2017-02-23
License: https://open.fda.gov/license/

Medical Components, Inc. / initiated 2017-02-23 / Terminated / root cause: labeling and UDI

FDA source

Medical Components, Inc dba MedComp began a recall of 9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The CT Power Injectable Implantable Infusion Ports are indicated for patient therapies... on 2017-02-23. FDA classified it as Class II and gives the reason as "The 9.6F port kits were packaged with the incorrect valved peelable introducer. The label states the kit contains a 10F valved peelable introducer. The kit is packaged with a 9F valved peelable introducer. The port...". 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-1536-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-23
Posted: 2017-03-08
Terminated: 2018-02-02
Recalling firm: Medical Components, Inc.
Product: 9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The CT Power Injectable Implantable Infusion Ports are 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 9.6F port kits were packaged with the incorrect valved peelable introducer. The label states the kit contains a 10F valved peelable introducer. The kit is packaged with a 9F valved peelable introducer. The port lumen will not fit through the introducer during the insertion procedure.
Root cause tag: labeling and UDI
FDA root cause: Unknown/Undetermined by firm
Action: Medcomp mailed a Customer Notification letter dated February 23, 2017, to all affected customers to inform them of the issue. Customers were asked to examine their inventory and return all unused product. Distributors were also asked to locate the end user/facility of where the affected product was sold and communicate the recall to them. Customers were instructed to contact their customer service representative for a Returned Goods Authorization (RGA) number if necessary at 215-256-4201. Customers were also instructed to complete and return page 2 of the letter by fax to 215-256-9191. For questions regarding this recall call 215-256-4201.
Quantity in commerce: 71 units
Distribution: Worldwide Distribution to PR and Panama
Product codes and lots: MRCTI96801 Lot# MHWQ060 S2 , UDI# 884908031232

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1536-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1536-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-22

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)