Baxter Healthcare Corp.: Medical Device Recall in 2014 - (Recall #: Z-0607-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: November 8, 2013

Date Posted: January 8, 2014

Recall Number: Z-0607-2014

Event ID: 66979

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.

Status: Terminated

Product Quantity: 28 devices

Code Information:

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.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated