Z-0937-2013Class II

Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with...

Name: Z-0937-2013 Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with...
Creator: Vygon Corporation
Published: 2012-12-17
License: https://open.fda.gov/license/

Vygon U.S.A. / initiated 2012-12-17 / Terminated / root cause: labeling and UDI

FDA source

Vygon Corporation began a recall of Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central... on 2012-12-17. FDA classified it as Class II and gives the reason as "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 labeling and UDI.

Recall record

Recall number: Z-0937-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-17
Posted: 2013-03-11
Terminated: 2014-01-14
Recalling firm: Vygon U.S.A.
Product: Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter.
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: 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: labeling and UDI
FDA root cause: Component change control
Action: Churchill Medical Systems sent a letter to their consignees on December 19, 2012.
Quantity in commerce: 210
Distribution: Product was distributed to 4 hospitals (under one hospital network) within the State of Pennsylvania
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-0937-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0937-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-20	2013-03-11

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)