Z-1527-2015Class II

9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an...

Name: Z-1527-2015 9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an...
Creator: Medical Components, Inc dba MedComp
Published: 2015-01-28
License: https://open.fda.gov/license/

Medical Components, Inc. / initiated 2015-01-28 / Terminated

FDA source

Medical Components, Inc dba MedComp began a recall of 9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a... on 2015-01-28. FDA classified it as Class II and gives the reason as "The dual port with catheters was not covered under FDA clearance". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1527-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-28
Posted: 2015-04-27
Terminated: 2017-01-06
Recalling firm: Medical Components, Inc.
Product: 9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a detachable catheter. The port systems provide repeated vascular access and are applicable for delivery of: medications, intravenous fluids, blood products, parenteral nutrition, and for venous blood sampling.
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: The dual port with catheters was not covered under FDA clearance.
FDA root cause: PMA
Action: Sales reps were notified by email on/about January 28, 2015, and instructed to notify their medical facilities and provide the recall letter. This will be accomplished by either email, telephone, or visit. Every consignee will be requested to complete and return Page 2 of the recall letter verifying receipt of the recall and disposition of the product they received.
Quantity in commerce: 325
Distribution: Worldwide distribution. US nationwide, Canada, Brazil, and United Arab Emirates.
Product codes and lots: Model No. MR592090A, MR592090P; with Lot Nos.: MAKT120 EXP. DATE 04/28/2012, MAXH410 EXP. DATE 06/28/2014, MAXF610 EXP. DATE 10/28/2014, MBFC140 EXP. DATE 05/28/2016, MBGH020 EXP. DATE 08/28/2016, MBHS100 EXP. DATE 11/28/2016, MAKT130 EXP. DATE 04/28/2012, MBAQ860 EXP. DATE 07/28/2015, MBHP980 EXP. DATE 11/28/2016, MBKJ110 EXP. DATE 03/28/2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1527-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1527-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-27

Product code LJT

K000125Class IIJet Port Plus Catheter SystemClinical Plastic Products SA / cleared 2000-04-12

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)