Z-1868-2012Class II

MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane...

Name: Z-1868-2012 MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane...
Creator: Medical Components, Inc dba MedComp
Published: 2012-04-02
License: https://open.fda.gov/license/

Medical Components, Inc. / initiated 2012-04-02 / Terminated / root cause: packaging

FDA source

Medical Components, Inc dba MedComp began a recall of MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power Injectable Implantable Infusion Port... on 2012-04-02. FDA classified it as Class II and gives the reason as "Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low Profile Pro-Fuse CT Port. The kit contains an 8F Midsize Dignity CT Port". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1868-2012
Classification: Class II
Status: Terminated
Initiated: 2012-04-02
Posted: 2012-06-26
Terminated: 2013-05-20
Recalling firm: Medical Components, Inc.
Product: MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power Injectable Implantable Infusion Port insertion kit.
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low Profile Pro-Fuse CT Port. The kit contains an 8F Midsize Dignity CT Port.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: MedComp sent a "PRODUCT ALERT" letter dated April 2, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The firm requested the return of all affected product. Contact the firm at 215-256-4201 ext. 2225 for questions regarding this notice.
Quantity in commerce: 30
Distribution: Worldwide Distribution-USA (nationwide) including the states of GA and WA and the countries of Ireland and Turkey.
Product codes and lots: Catalog number MRCTT80041, Lot # MDNK860, Exp 02/2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1868-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1868-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-26

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)