Z-2235-2010

medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low Profile CT Port with Pre-Attached Chronoflex(R) Polyurethane...

Name: Z-2235-2010 medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low Profile CT Port with Pre-Attached Chronoflex(R) Polyurethane...
Creator: Medical Components, Inc dba MedComp
Published: 2010-07-02
License: https://open.fda.gov/license/

Medical Components, Inc. / initiated 2010-07-02 / Terminated / root cause: manufacturing process

FDA source

Medical Components, Inc dba MedComp began a recall of medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low Profile CT Port with Pre-Attached Chronoflex(R) Polyurethane Catheter - 1 Unit. Catalog #MRCTI66841 on 2010-07-02. The reason FDA records is "Recalled product was packaged with the incorrect port and does not match the label. The kit is labeled as a 6.6F "Dignity" Low Profile CT Port. The kit contains a 6.6F "Pro-Fuse" Low Profile 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-2235-2010
Status: Terminated
Initiated: 2010-07-02
Posted: 2010-08-17
Terminated: 2010-10-13
Recalling firm: Medical Components, Inc.
Product: medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low Profile CT Port with Pre-Attached Chronoflex(R) Polyurethane Catheter - 1 Unit. Catalog #MRCTI66841.
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: Recalled product was packaged with the incorrect port and does not match the label. The kit is labeled as a 6.6F "Dignity" Low Profile CT Port. The kit contains a 6.6F "Pro-Fuse" Low Profile CT Port.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Medcomp sales reps and foreign distributor were notified via email on 7/1/10. Product is to be returned to Medcomp.
Quantity in commerce: 47 units
Distribution: Worldwide Distribution -- USA, including states of NC and TX and country of Israel.
Product codes and lots: Lot #MAZL630, Exp. 04/2015

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)