FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: 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.
- Recall number
- Z-0607-2014
- Recalling firm
- Baxter Healthcare Corp.
- 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.
- Status
- Terminated
- Initiated
- 2013-11-08
- Posted
- 2013-12-29
- Terminated
- 2015-03-23
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NEP
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28