Z-1482-2017Class II

MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are used to...

Name: Z-1482-2017 MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are used to...
Creator: CareFusion 303, Inc.
Published: 2017-02-20
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2017-02-20 / Terminated

FDA source

CareFusion 303, Inc. began a recall of MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are used to administer fluids from a container to a patient s... on 2017-02-20. FDA classified it as Class II and gives the reason as "CareFusion is recalling the MaxGuard Extension Set due to reports of leaks occurring with the 0.2 micron filter". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1482-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-20
Posted: 2017-02-28
Terminated: 2018-10-29
Recalling firm: CareFusion 303, Inc
Product: MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are used to administer fluids from a container to a patient s vascular system through a needle or catheter inserted into the patient s artery or vein. The extension sets may incorporate components that aid in the prevention of accidental needle sticks. The set s components are commonly found on intravascular administration sets and extension sets
Product code: FPA Set, Administration, Intravascular
Reason for recall: CareFusion is recalling the MaxGuard Extension Set due to reports of leaks occurring with the 0.2 micron filter.
FDA root cause: Under Investigation by firm
Action: CareFusion sent an Urgent Medical Device Recall Notification letter dated February 2017 to all affected customers inform them that CareFusion is recalling the MaxGuard Extension Set model codes ME20164, MP9009-C, MP9209, MP9254-C with multiple lot numbers. CareFusion has received reports of leaks occurring with the 0.2 micron filter. Customers were informed that leakages on an extension can cause delay of infusion, interruption of infusion, exposure to medication or hazardous infusates, underinfusion or air in line. Customers were instructed to discontinue use of the affected product and contact CareFusion for a replacement lot. The letter informs the customers of the actions to be taken and for recall related questions to contact CareFusion Support Center at (888) 562-6018. Customers with adverse event reports are instructed to contact Customer Advocacy at (888) 812-3266. Customers were also instructed to immediately complete and return to CareFusion the enclosed, pre-addressed and postage paid, Recall Response Card.
Quantity in commerce: 12,850 units
Distribution: Nationwide Distribution
Product codes and lots: Lot No. 15045419 15075822 15086644 16036290 16056204 16075270 15086404 16067461 16046571 16045810

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1482-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1482-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-16

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)