Z-1626-2012

8F Plastic Dignity Mid-Sized CT Port w/Silicone Filled Suture Holes and w/Attachable ChronoFlex Polyurethane...

Name: Z-1626-2012 8F Plastic Dignity Mid-Sized CT Port w/Silicone Filled Suture Holes and w/Attachable ChronoFlex Polyurethane...
Creator: Medical Components, Inc dba MedComp
Published: 2012-04-12
License: https://open.fda.gov/license/

Medical Components, Inc. / initiated 2012-04-12 / Terminated / root cause: manufacturing process

FDA source

Medical Components, Inc dba MedComp began a recall of 8F Plastic Dignity Mid-Sized CT Port w/Silicone Filled Suture Holes and w/Attachable ChronoFlex Polyurethane Catheter. Catalog # MRCTI8000S. The Power... on 2012-04-12. The reason FDA records is "50 trays of Dignity Low Profile CT Port were labeled as Dignity Mid-Sized CT Port". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1626-2012
Status: Terminated
Initiated: 2012-04-12
Posted: 2012-05-18
Terminated: 2013-07-18
Recalling firm: Medical Components, Inc.
Product: 8F Plastic Dignity Mid-Sized CT Port w/Silicone Filled Suture Holes and w/Attachable ChronoFlex Polyurethane Catheter. Catalog # MRCTI8000S. The Power Injectable, Implantable Infusion Port is an implantable single fluid reservoir port with a polyurethane (8F) catheter attachable for application by the inserting physician.
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: 50 trays of Dignity Low Profile CT Port were labeled as Dignity Mid-Sized CT Port.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On April 12, 2012, MedComp sales representatives and the foreign distributor were notified via e-mail with a "Product Alert" notification. The issue was described and requested actions were provided to recipients.
Quantity in commerce: 50 trays
Distribution: Worldwide Distribution - - USA, including the states of CA, NJ, AZ, PA, TN and the country of Spain.
Product codes and lots: Lot #MDPZ600 Expiration date 2015/02

Product code LJT

K070003Class IIPower Injectable Implantable Infusion Port with Silicone Lumen (Attachable and Pre-Attached)Medcomp / cleared 2007-05-15

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)