FDAFDA · Food and drugs·Recall number Z-0607-2014
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.
Published January 8, 2014 · Recall initiated: November 8, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corp.
- Distributor
- 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
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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