Z-0607-2014Class II

IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syringes from 0.5mL up to 11.5mL using...

Name: Z-0607-2014 IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syringes from 0.5mL up to 11.5mL using...
Creator: Baxter Healthcare Corp.
Published: 2013-11-08
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2013-11-08 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corp. began a recall of IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syringes from 0.5mL up to 11.5mL using mixing instructions from its formulary to fill the... on 2013-11-08. FDA classified it as Class II and gives the reason as "Following a retrospective review for Baxter Daytona Complaint CR-954, it was identified that the IntelliFill i.v. Pharmacy Compounding Device (PCD) (product code: IFIV) has the potential to continue to run and fill...". 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-0607-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-08
Posted: 2013-12-29
Terminated: 2015-03-23
Recalling firm: Baxter Healthcare Corporation
Product: IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syringes from 0.5mL up to 11.5mL using mixing instructions from its formulary to fill the orders.
Product code: NEP System/Device, Pharmacy Compounding
Reason for recall: Following a retrospective review for Baxter Daytona Complaint CR-954, it was identified that the IntelliFill i.v. Pharmacy Compounding Device (PCD) (product code: IFIV) has the potential to continue to run and fill syringes with the HEPA filtration disabled.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: A Service Bulletin was sent to all IntelliFill i. v. customers February 22, 20 I 0 by USPS mail. The Service Bulletin informs customers that IntelliFill i.v. operators are to be trained to listen for the running HEPA filtration fan motor and observe/feel for airflow coming from the automation deck. The field service engineer dispatched to the site replaced the damaged sensor on 11-Feb-2010 and a Service Bulletin was sent to all customers regarding the function and use of the HEPA filter on 22-Feb-2010. A new HEPA sensor was designed and installed into all current IntelliFill i.v. devices between 21-July-2011 to 9-Feb-2012.
Quantity in commerce: 28 devices
Distribution: Nationwide Distribution including the states of CA, CO, CT, FL, IL, LA, MA, MD, MI, NC, NE, NY, OH, OR, PA, TN, TX, and WV.
Product codes and lots: Lot # 123, 125R, 127, 129, 145, 146R, 147R, 148, 215R, 500, 501, 502, 503, 504, 505, 506, 508, 510, 511R, 512, 514, 515, 516R, 517, 518, 519, and 520.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0607-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0607-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-08	2013-12-29

Product code NEP

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)