Z-0607-2014 Class II Terminated
FDA device recall Z-0607-2014 was initiated by Baxter Healthcare Corp. on Nov 8, 2013 and is designated Class II. 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… The recall status is terminated (terminated Mar 23, 2015). Affected quantity: 28 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 8, 2014
- Initiation Date
- Nov 8, 2013
- Termination Date
- Mar 23, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28 devices
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.
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.
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.
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0607-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026