Z-0898-2013Class II

REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components

Name: Z-0898-2013 REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components
Creator: Medical Components, Inc dba MedComp
Published: 2012-12-13
License: https://open.fda.gov/license/

Medical Components, Inc. / initiated 2012-12-13 / Terminated / root cause: manufacturing process

FDA source

Medical Components, Inc dba MedComp began a recall of REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits on 2012-12-13. FDA classified it as Class II and gives the reason as "The affected product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle". 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-0898-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-13
Posted: 2013-02-28
Terminated: 2013-07-31
Recalling firm: Medical Components, Inc.
Product: REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: The affected product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Medcomp sent a notification letter dated December 13, 2012 via email to all affected customers. The letter identified the affected product, problem and actions to be taken. For questions or concerns call 215-256-4201
Quantity in commerce: 785
Distribution: USA Nationwide Distribution including the state of PA.
Product codes and lots: Lots numbers MBKQ640, exp 05/2015; MBKZ720, exp 05/2015; MBLJ290, exp 06/2015; MBLR100, exp 07/2015; MBLZ350, exp 09/2015; and MBMG250, exp 10/2015.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0898-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0898-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-06	2013-02-28

Product code LJS

K081904Class IIPro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full Nursing Tray)Medcomp / cleared 2008-09-23

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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)