Z-1464-2017Class II

MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305

Name: Z-1464-2017 MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305
Creator: CareFusion 303, Inc.
Published: 2017-02-20
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2017-02-20 / Terminated / root cause: manufacturing process

FDA source

CareFusion 303, Inc. began a recall of MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305 on 2017-02-20. FDA classified it as Class II and gives the reason as "CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter because of reports of separation and/or leakages between the Y-connector and tubing". 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-1464-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-20
Posted: 2017-02-28
Terminated: 2017-11-17
Recalling firm: CareFusion 303, Inc
Product: MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305
Product code: FPA Set, Administration, Intravascular
Reason for recall: CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter because of reports of separation and/or leakages between the Y-connector and tubing.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An Urgent Medical Device Recall Notification letter will be sent to customers on February 20, 2017 to inform them that CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter model number ME3305 Lot Number 16016790. Customers are informed that CareFusion has received reports of separation and/or leakages between theY-connector and tubing. Customers are informed that leakages from an extension set can cause delay of infusion, interruption of infusion, exposure to medication or hazardous infusates, or underinfusion. 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.
Quantity in commerce: 1,200 units
Distribution: US Distribution including MA and MD
Product codes and lots: Lot No. 16016790

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1464-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1464-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-14

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)