Z-0931-2014Class II

Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230

Name: Z-0931-2014 Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230
Creator: CareFusion 303, Inc.
Published: 2014-01-16
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2014-01-16 / Terminated / root cause: manufacturing process

FDA source

CareFusion 303, Inc. began a recall of Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230 on 2014-01-16. FDA classified it as Class II and gives the reason as "CareFusion is recalling the Trifurcated Extension Set, models ME 1224 and MP 9230, because they may have a defect in the trifurcated component that could result in a component leak". 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-0931-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-16
Posted: 2014-02-04
Terminated: 2014-08-06
Recalling firm: CareFusion 303, Inc
Product: Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.
Product code: FPA Set, Administration, Intravascular
Reason for recall: CareFusion is recalling the Trifurcated Extension Set, models ME 1224 and MP 9230, because they may have a defect in the trifurcated component that could result in a component leak.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: A customer notification letter and a distribution letter are dated 1/22/14 were sent to customers to inform them that CareFusion is recalling the Trifurcated Extension Set, models ME 1224 and MP 9230 may have a defect in the trifurcated component that could result in the component to leak. The letters inform the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return to CareFusion the enclose, pre-addressed and postage paid, recall response card. Customers are instructed that once CareFusion receives the recall response card, the CareFusion Support Center will provide instructions for return of the affected lot number and replacement of the affected lot. Customers are instructed to contact CareFusion Support Center at (888) 562-6018, Customer advocacy at (888) 812-3266, [email protected], or technical support at (888) 812-3229.
Quantity in commerce: 9,550 units
Distribution: Nationwide in US and Canada
Product codes and lots: Trifurcated Extension Set, Model No. ME 1224, Lot No. 11066540 11075718 11085047 11086237 11086676 11095178 11096312 11106045 11126756 12025801 12037064 12037127 12065225 12065586 12076327 12095460 13025322 13035514 13076233 13085002 Trifurcated Extension Set, Model No. MP 9230 Lot No. 13015666.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0931-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0931-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-12	2014-02-04

Product code FPA

K051499Class IIIntravascular Administration Set and Extension SetMedegen Medical Manufacturing Services / cleared 2005-06-22

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)